510(k) K072438
K072438 is an FDA 510(k) premarket notification submitted by Monarch Labs, LLC for the device "MEDICAL MAGGOTS, CREATURE COMFORTS". The FDA issued a decision of Substantially Equivalent on October 5, 2007. The device falls under product code NQK (Maggots, Medical), a Class U device. Monarch Labs, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2007
- Date Received
- August 30, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Maggots, Medical
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
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)