510(k) K101793 ยท FRO Dressing, Wound, Drug
MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
| Applicant | Derma Sciences, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Feb 22, 2011 |
| Received | Jun 28, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101793
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2026 | Integra LifeSciences Corp. (NeuroSciences) MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815.
MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healin Open, Classified |
FRO | None listed |
| Feb 12, 2025 | Integra LifeSciences Corp. Brand Name: MediHoney Gel
Product Name: MediHoney Wound & Burn Dressing Gel
Model/Catalog Number: 31815
Software Version: N/A
Product Description: MediHoney Gel with Active Leptospermum Honey is a moi Open, Classified |
FRO | None listed |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS Open, Classified |
FRO | None listed |
| Mar 6, 2018 | Integra LifeSciences Corp. Manuka Honey Wound Gel
Catalogue No: 716597
Product Usage:
Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lace Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.