510(k) K123449
K123449 is an FDA 510(k) premarket notification submitted by Biomonde (A Trading Name of Zoobiotic Limited) for the device "BIOMONDE LARVAE". The FDA issued a decision of Substantially Equivalent on March 5, 2013. The device falls under product code NQK (Maggots, Medical), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2013
- Date Received
- November 9, 2012
- 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)