NQK · Maggots, Medical
· Class U
Overview
| Product Code | NQK |
|---|---|
| Device Name | Maggots, Medical |
| Device Class | Class U |
| Review Panel |
Identification
Phaenicia sericacta (blow fly) larvae are harvested and provided disinfected for use in debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds. See Federal Register Notice at 89 FR 106521 Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches (FRN) (FDA-2024-N-5702)
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K142020 | LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 | Biomonde | Nov 5, 2014 | SESE |
| K131221 | LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 | Biomonde | Aug 28, 2013 | SESE |
| K123449 | BIOMONDE LARVAE | Biomonde (A Trading Name of Zoobiotic Limited) | Mar 5, 2013 | SESE |
| K102827 | MEDICAL MAGGOTS, LESOC | Monarch Labs, LLC | Nov 2, 2011 | SESE |
| K072438 | MEDICAL MAGGOTS, CREATURE COMFORTS | Monarch Labs, LLC | Oct 5, 2007 | SESE |
| K033391 | MEDICAL MAGGOTS | Ronald A. Sherman | Jan 12, 2004 | SESE |
Top Applicants
- Biomonde — 2 clearances
- Monarch Labs, LLC — 2 clearances
- Biomonde (A Trading Name of Zoobiotic Limited) — 1 clearance
- Ronald A. Sherman — 1 clearance
