NQK — Maggots, Medical Class U
FDA product code NQK covers "Maggots, Medical", a Class U medical device. Submissions are reviewed by the Unknown panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NQK
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Definition
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 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K142020 | biomonde | LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/3 | November 5, 2014 |
| K131221 | biomonde | LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 | August 28, 2013 |
| K123449 | biomonde (a trading name of zoobiotic limited) | BIOMONDE LARVAE | March 5, 2013 |
| K102827 | monarch labs | MEDICAL MAGGOTS, LESOC | November 2, 2011 |
| K072438 | monarch labs | MEDICAL MAGGOTS, CREATURE COMFORTS | October 5, 2007 |
| K033391 | ronald a. sherman | MEDICAL MAGGOTS | January 12, 2004 |