Cleared Traditional

K971918 - AMERIGEL OINTMENT SATURATED WOUND DRESSING

K971918 · Amerx Health Care Corp. · General & Plastic Surgery device
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Aug 1997
Decision
81d
Days
-
Risk

K971918 is an FDA 510(k) clearance for the AMERIGEL OINTMENT SATURATED WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Amerx Health Care Corp. (Clearwater, US). The FDA issued a Cleared decision on August 12, 1997 after a review of 81 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 Amerx Health Care Corp. devices

FDA 510(k) Submission Details - K971918

510(k) Number K971918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1997
Decision Date August 12, 1997
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
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 19
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K971918.
NU-GEL * WOUND DRESSING
K983362 · Johnson & Johnson Medical, Inc. · Dec 1998
SWEEN WOUN'DRES
K983042 · Coloplast Corp. · Nov 1998
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · Smith & Nephew, Inc. · Jun 1998
B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
K970453 · B.Braun Medical, Inc. · Apr 1997
DERMAPLEX HYDROGEL WOUND DRESSING
K962513 · Maxxim Medical · Sep 1996
AQUAFLO BTP HYDROGEL WOUND DRESSING
K952938 · Sherwood Medical Co. · Dec 1995