Maggots, Medical
Medical maggots (Phaenicia sericata blow fly larvae) are harvested and provided in a disinfected form for use in debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and traumatic or post-surgical wounds. This product is classified as unclassified (FDA unclassified) under product code NQK, with regulatory oversight being transferred from the Center for Devices and Radiological Health (CDRH) to the Center for Biologics Evaluation and Research (CBER) per Federal Register Notice 89 FR 106521. It is not an implant or life-sustaining device and has no applicable regulation number.
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Basic Information
- Product Code
- NQK
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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)
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K142020 | LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 | Nov 05, 2014 | Substantially Equivalent | Biomonde |
| K131221 | LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 | Aug 28, 2013 | Substantially Equivalent | Biomonde |
| K123449 | BIOMONDE LARVAE | Mar 05, 2013 | Substantially Equivalent | Biomonde (A Trading Name of Zoobiotic Limited) |
| K102827 | MEDICAL MAGGOTS, LESOC | Nov 02, 2011 | Substantially Equivalent | Monarch Labs, LLC |
| K072438 | MEDICAL MAGGOTS, CREATURE COMFORTS | Oct 05, 2007 | Substantially Equivalent | Monarch Labs, LLC |
| K033391 | MEDICAL MAGGOTS | Jan 12, 2004 | Substantially Equivalent | Ronald A. Sherman |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.