← Product Code [GAM](/productcode/GAM) · K060801 # DEKNA-LOK MODEL BP1000V2L (K060801) _Teleflex Medical · GAM · May 17, 2006 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K060801 ## Device Facts - **Applicant:** Teleflex Medical - **Product Code:** [GAM](/productcode/GAM.md) - **Decision Date:** May 17, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4493 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use Dekna-lok™ is indicated for use in general soft tissue approximation and/or ligation, but not for cardiovascular, neurological or ophthalmic procedures. ## Device Story Dekna-lok™ consists of Deknatel® Bondek® Plus polyglycolic acid synthetic absorbable suture integrated with two acetal polymer buttressing components. Buttressing components distribute suture pressure across tissue. Device used by clinicians for soft tissue approximation and ligation. Benefits include reduced tissue pressure via buttressing. No complex electronics or software involved. ## Clinical Evidence Bench testing only. Materials evaluated per USP 28:2005 Absorbable Surgical Sutures and ISO 10993 Part 1 biological safety standards. Design and materials validated via risk analysis. ## Technological Characteristics Polyglycolic acid synthetic absorbable suture with acetal polymer buttressing components. Evaluated per USP 28:2005 and ISO 10993-1. No software or electronic components. ## Regulatory Identification An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached. ## Special Controls *Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document. ## Predicate Devices - Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture ([K992088](/device/K992088.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 060801 Image /page/0/Picture/1 description: The image shows the logo for Teleflex Medical. The word "Teleflex" is in a bold, sans-serif font, with a stylized "T" that resembles a right angle. Below "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is in black and white. page 1/2 v + 7 0006 Teleflex Medical 2917 Weck Drive RTP. NC 27709 USA 919-544-8000 Phone: Fax: 919-361-4061 www.teleflex.com ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dekna-lok™ # A. Name, Address, Phone and Fax Number of Applicant Teleflex Medical 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-361-8000 Fax: 919-361-4061 ### B. Contact Person Kimberly Edgerton Regulatory Affairs Specialist ### C. Date Prepared March 23, 2006 #### D. Device Name Trade Name: Dekna-lok™ Common Name: Polyglycolytic Acid Surgical Suture Classification Name: Absorbable poly(glycolide/l-lactide) surgical suture Product Code: GAM Regulation Number: 21 CFR 878.4493 Class: Il # E. Device Description Dekna-lok™ is Deknatel® Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture supplied with two integral acetal polymer buttressing components designed to spread the pressure of the suture across tissue. A Division of Teleflex Incorporated BERATE | HUDSON RCI | KMedic | Filling | MBR-EMC | RUSCH | WECK {1}------------------------------------------------ #### F. Intended Use Dekna-lok™ is indicated for use in general soft tissue approximation and/or ligation, but not for cardiovascular, neurological or ophthalmic procedures. ### G. Substantial Equivalence Dekna-lok™ is substantially equivalent to Teleflex Medical's Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture (K992088) with respect to functionality, design, and intended use and performance characteristics. #### H. Summary of Testing All materials used in the fabrication of Dekna-lok™ were evaluated through the recognized consensus standards as outlined in USP 28:2005 Absorbable Surgical Sutures and biological qualification safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices". Verification and Validation testing was performed according to the risk analysis. The design and materials were found to be acceptable for the intended use. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA", which is arranged in a circular fashion around the left side of the logo. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # MAY 17 2006 Teleflex Medical % Ms. Kimberly Edgerton Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709 Re: K060801 Trade/Device Name: Dekna-lok™ Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: March 23, 2006 Received: March 24, 2006 Dear Ms. Edgerton: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set {3}------------------------------------------------ #### Page 2 - Ms. Kimberly Edgerton forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Hubert Werner ws Mark N. Melkerson Director Division of General, Restorative and.Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Teleflex Medical. The logo is in black and white, with the word "Teleflex" in a bold, sans-serif font. Below the word "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is simple and modern. K060801 Teleflex Medical 2917 Weck Drive RTP, NC 27709 USA Phone: 919-544-8000 Fax:919-361-4061 www.teleflex.com 、中国人民共和国际 # Indications for Use 510(k) Number (if known): Device Name: Dekna-lok TM Indications For Use: Dekna-lok™ is indicated for use in general soft tissue approximation and/or ligation, but not for cardiovascular, neurological or ophthalmic procedures. Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (Of Page 1 of 1 uation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K060801 A Division of Teleflex Incorporated | HUDSON RC/ | KMedic | Filling | PLAR-EUC | RUSCH | WECK --- **Source:** [https://fda-staging.innolitics.com/device/K060801](https://fda-staging.innolitics.com/device/K060801) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com