CUSTOM CV PACK

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 7, 2025 Associated Medical Scott Wiest Operations Manager 11140 Bren Road West Minnetonka, Minnesota 55343 Re: K936255 Trade/Device Name: Custom CV Pack Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: KDD Dear Scott Wiest: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 31, 1994. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code KDD. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov. Sincerely, Julie A. Morabito - S DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} [LOGO] DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service MAR 31 1994 Food and Drug Administration 1390 Piccard Drive Rockville MD 20850 Mr. Scott Wiest Operations Manager Associated Medical 11140 Bren Road West Minnetonka, Minnesota 55343 Re: K936255 Custom CV Pack Regulatory Class: II Dated: March 21, 1994 Received: March 24, 1994 Dear Mr. Wiest: 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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). However, you are responsible to determine that the medical devices you use as components in the Custom CV Pack have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the Act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and 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. In addition, the Food and Drug Administration (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 the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations. {2} Page 2 - Mr. Scott Wiest In addition, we have determined that your product contains the following component subject to regulation as a drug: 1. 2 each PVP Solution Our substantially equivalent determination does not apply to the drug component of your product. For information on applicable Agency requirements for marketing this product, we suggest you contact: Director Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 295-8063 This letter will allow you to begin marketing your device as described although we recommend that you first contact the Center for Drug Evaluation and Research before marketing your drug components. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice on the labeling for your device please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-326) at (301) 594-4639. Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597. Sincerely yours, Paul R. Beninger, M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health 8