510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K102827Substantially Equivalent

Medical Maggots, Lesoc

Monarch Labs, LLC, Irvine CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102827 is the FDA 510(k) clearance record for MEDICAL MAGGOTS, LESOC, cleared for Monarch Labs, LLC on under FDA product code NQK (Maggots, Medical). FDA's definition for product code NQK 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...". FDA records list 2 510(k) clearances for Monarch Labs, LLC, from to . As of , FDA records show no recalls naming K102827.

Clearance record

Decision date
Received
(399 days to decision)
Product code
NQK Maggots, Medical
Device class
Unclassified
Review panel
Unknown
Applicant
Monarch Labs, LLC 17875 Sky Park Cir., Suite K, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQK

Trailing 12 months

FDA records hold no clearances under product code NQK in the trailing twelve months.

FDA records show no clearances under product code NQK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NQK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260