Atlas FDA

NQK

6 FDA 510(k) clearances · Product code

116 daysmedian time to decision
399 days90th percentile
6clearances measured

FDA profile

Official device name
Maggots, Medical
Device class
Unclassified
Medical specialty
Unknown
FDA 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)
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RecordFirmDate
LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 (K142020)Biomonde2014-11-05
LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 (K131221)Biomonde2013-08-28
BIOMONDE LARVAE (K123449)Biomonde (A Trading Name of Zoobiotic Limited)2013-03-05
MEDICAL MAGGOTS, LESOC (K102827)Monarch Labs, LLC2011-11-02
MEDICAL MAGGOTS, CREATURE COMFORTS (K072438)Monarch Labs, LLC2007-10-05
MEDICAL MAGGOTS (K033391)Ronald A. Sherman2004-01-12

Track NQK automatically

Every clearance here is in the API, with alerts when new ones post.