Medical Device
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DEN070002Unknown

Qmt Nimbus Antimicrobial Barrier Gauze Dressing

Quick-Med Technologies, Inc., Gainesville FL / Post-NSE, Unknown

DEN070002 is the FDA 510(k) clearance record for QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING, a class II device, cleared for Quick-Med Technologies, Inc. on under FDA product code NYS (Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)). FDA's definition for product code NYS reads: "A wound dressing with poly (diallyl dimethyl ammonium chloride) (pdadmac) additive is a device that is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical...". FDA records list 2 510(k) clearances for Quick-Med Technologies, Inc., from to . As of , FDA records show no recalls naming DEN070002.

Clearance record

Decision date
Received
(657 days to decision)
Product code
NYS Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
Regulation
21 CFR 878.4015
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Quick-Med Technologies, Inc. 3427 SW 42nd Way, Gainesville FL
Third party review
No

Clearances, product code NYS

Trailing 12 months

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

FDA records show no clearances under product code NYS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NYS, 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