← Product Code [GEI](/productcode/GEI) · K992186 # QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT (K992186) _Conmedcorp · GEI · Jul 30, 1999 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K992186 ## Device Facts - **Applicant:** Conmedcorp - **Product Code:** [GEI](/productcode/GEI.md) - **Decision Date:** Jul 30, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use For use in laparoscopic and open surgical procedures to provide r of ass iral cutting and electrosurgical hemostasis of tissue as well as grasping and manipulation of the tissue. ## Device Story ConMed QUAD™ is a bipolar laparoscopic instrument; used in laparoscopic and open surgical procedures. Device provides electrosurgical cutting and hemostasis; enables grasping and manipulation of tissue. Operated by surgeons in clinical/OR settings. Device functions by delivering bipolar electrical energy to target tissue; allows simultaneous or sequential cutting and coagulation. Benefits include reduced surgical time and improved hemostasis control during procedures. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Bipolar electrosurgical instrument; laparoscopic and open surgical form factor. Materials and dimensions consistent with standard surgical instrumentation. Energy source: Bipolar electrosurgical generator. ## Regulatory Identification An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle's perimeter. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 30 1999 Mr. Ira D. Duesler, Jr. Quality Engineer ConMed Corporation 310 Broad Street Utica, New York 13350 K992186 Re: Trade Name: ConMed QUAD™ Bipolar Laparoscopic Coagulating And Cutting Instrument Regulatory Class: II Product Code: GEI Dated: June 28, 1999 Received: June 29, 1999 Dear Mr. Duesler: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1}------------------------------------------------ Page 2 - Mr. Ira D. Duesler, Jr. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known): Device Name: ConMED QUAD™ Bipolar Laparoscopic Coagulating and Cutting Instrument Indications for Use: For use in laparoscopic and open surgical procedures to provide r of ass iral cutting and electrosurgical hemostasis of tissue as well as grasping and manipulation of the tissue. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|---------| | (Division Sign-Off) | | | Division of General Restorative Devices | | | 510(k) Number | K992186 | Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter _____________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda-staging.innolitics.com/device/K992186](https://fda-staging.innolitics.com/device/K992186) **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. 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