CURAGEL HYDROGEL WOUND DRESSING

{0} **FDA U.S. FOOD & DRUG** ADMINISTRATION February 25, 2025 Kendall Healthcare Products Company A Division of the Kendall Company David A. Olson Regulatory Affairs Specialist 15 Hampshire Street Mansfield, Massachusetts 02048 Re: K950412 Trade/Device Name: Border (Island) and Borderless Kendall CURAGEL Hydrogel Wound Dressings Regulation Number: 21 CFR 878.4022 Regulation Name: Hydrogel wound dressing and burn dressing Regulatory Class: Class I Product Code: NAE Dear David A. Olson: 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 24, 1995. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code NAE. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, 301-796-6196, Yu-Chieh.Chiu@fda.hhs.gov. Sincerely, **Yu-chieh Chiu -S** Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive 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 24 1995 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 Mr. David A. Olson Regulatory Affairs Specialist Kendall Healthcare Products Company A Division of the Kendall Company 15 Hampshire Street Mansfield, Massachusetts 02048 Re: K950412 Border (Island) and Borderless Kendall CURAGEL Hydrogel Wound Dressings Regulatory Class: Unclassified Product Code: MGQ Dated: January 30, 1995 Received: January 31, 1995 Dear Mr. Olson: We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 your devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations: 1. This devices may not be labeled for use on third degree burns. 2. This devices may not be labeled as having any accelerating effect on the rate of wound healing or epithelization. 3. This devices may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin. 4. This devices may not be labeled as a treatment or a cure for any type of wound. The labeling claims listed above would be considered a major modification in the intended use of the devices and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration. {2} Page 2 - Mr. David A. Olson If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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 devices 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. This letter immediately will allow you to begin marketing your devices as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and permits your devices to proceed to the market, but it does not mean that FDA approves your devices. Therefore, you may not promote or in any way represent your devices or their labeling as being approved by FDA. If you desire specific advice regarding labeling for your devices in accordance with 21 CFR Part 801, promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) 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 Paul R. Beninger, M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health