Cleared Traditional

ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING (K974348) - FDA 510(k) Clearance

K974348 · Laboratoires Urgo S.A. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Laboratoires Urgo S.A. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 163
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K974348.
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · Medline Industries, Inc. · Jun 2005
ACTICOAT MOISTURE CONTROL DRESSING
K050030 · Smith & Nephew, Inc. · Apr 2005
3M TEGADERM SILVER
K040890 · 3M Company · Nov 2004
TEGASORB(TM) ULCER DRESSING, #90-XXX
K891288 · 3M Company · Jun 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · Baxter Healthcare Corp · Mar 1989
PHARMASEAL STERILE WOUND CARE DRESSING
K884397 · Baxter Healthcare Corp · Dec 1988