DeviceClearance

Product code NQK— Unknown

BIOMONDE LARVAE

Classification name
Maggots, Medical
Device class
Unclassified
Advisory panel
Unknown
Total cleared
6
First cleared
Most recent

FDA classification 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)”

— U.S. Food and Drug Administration, device classification record for product code NQK, via openFDA

Market context for product code NQK

FDA has cleared 6 devices under product code NQK between 2004 and 2014, filed by 4 applicant companies. No FDA device recalls reference this product code.

Clearances per year

Top applicants under product code NQK

Recent clearances under product code NQK

Data sourced from openFDA. This site is unofficial and independent of the FDA.