MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
FDA 510(k) clearance K101793 · decided 2011-02-22
Clearance details
- K-number
- K101793
- Device name
- MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
- Applicant
- Derma Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-28
- Decision date
- 2011-02-22
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. recall (Z-1363-2026) | Integra LifeSciences Corp. (NeuroSciences) | 2026-02-13 |
| Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog recall (Z-1168-2025) | Integra LifeSciences Corp. | 2025-02-12 |
| Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF recall (Z-1803-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-09-26 |