Cleared Traditional

K955400 - QUEGEL HYDROPHILIC WOUND DRESSING

K955400 · Questor Pharma, Inc. · General & Plastic Surgery device
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Feb 1996
Decision
77d
Days
-
Risk

K955400 is an FDA 510(k) clearance for the QUEGEL HYDROPHILIC WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Questor Pharma, Inc. (Winter Haven, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Questor Pharma, Inc. devices

FDA 510(k) Submission Details - K955400

510(k) Number K955400 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 24, 1995
Decision Date February 09, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 87
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K955400.
BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET
K961067 · Medtrak Intl., Inc. · May 1996
CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION)
K960428 · Carrington Laboratories, Inc. · Mar 1996
BURNAID BURN FIRST AID DRESSING
K953505 · Rye Pharmaceuticals Pty. , Ltd. · Feb 1996
IAMIN GEL WOUND DRESSING
K953853 · Procyte Corp. · Feb 1996
TECNOL HYDROGEL WOUND DRESSING
K955575 · Tecnol Medical Products, Inc. · Jan 1996
AQUAFLO BTP HYDROGEL WOUND DRESSING
K952938 · Sherwood Medical Co. · Dec 1995