Cleared Traditional

K974348 - ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING

K974348 · Laboratoires Urgo S.A. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
86d
Days
-
Risk

K974348 is an FDA 510(k) clearance for the ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Laboratoires Urgo S.A. (St Louis, US). The FDA issued a Cleared decision on February 13, 1998 after a review of 86 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.

FDA 510(k) Submission Details - K974348

510(k) Number K974348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1997
Decision Date February 13, 1998
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 652
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K974348.
SILVERLON CONTACT WOUND DRESSING
K981299 · Argentum International, LLC · Sep 1998
DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING
K980777 · Dumex Medical Surgical Products, Ltd. · May 1998
20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE
K972185 · Steripak, Ltd. · Mar 1998
DUODERM CONTROL GEL FORMULA BORDER DRESSING
K973688 · Convatec, Ltd. · Dec 1997
DUODERM HYDROACTIVE DRESSING
K973689 · Convatec, Ltd. · Dec 1997
DUODERM HYDROACTIVE PASTE
K973807 · Convatec, A Bristol-Myers Squibb Co. · Dec 1997
K974348 · ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING
Download PDF FDA Summary Laboratoires Urgo S.A.