510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NQKUnclassified

Maggots, Medical

Unknown
FDA source (opens on fda.gov)

NQK is the FDA product code for Maggots, Medical. FDA's definition for this code reads: "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...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NQK
Device name
Maggots, Medical
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)
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
1

Clearances, product code NQK

By decision year
6 clearances under product code NQK with a decision year between 2004 and 2014, 2013 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NQK by decision year
YearClearances
20041
20071
20111
20132
20141

Applicants with the most clearances

Product code NQK
Applicants holding the most 510(k) clearances under product code NQK
ApplicantClearances
Biomonde2
Monarch Labs, LLC2
Biomonde (A Trading Name of Zoobiotic Limited)1
Ronald A. Sherman1

Companies listing this code with FDA

Companies whose registered establishments list this code