Cleared Traditional

CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE (K850147) - FDA 510(k) Clearance

K850147 · Beiersdorf, Inc. · General & Plastic Surgery device
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Jul 1985
Decision
172d
Days
-
Risk

K850147 is an FDA 510(k) clearance for the CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 172 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Beiersdorf, Inc. devices

Submission Details

510(k) Number K850147 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 14, 1985
Decision Date July 05, 1985
Days to Decision 172 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 115d · This submission: 172d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K850147.
ACTISORB ACTIVATED CHARCOAL DRESSING
K860486 · Johnson & Johnson Professionals, Inc. · Mar 1986
TEGADERM PLUS TRANSPARENT DRESSING #952X
K852750 · 3M Company · Sep 1985
BAND-AID BRAND ADHESIVE BANDAGES
K852545 · Johnson & Johnson Professionals, Inc. · Sep 1985
BARD OCCLUSIVE WOUND DRESSING
K850889 · C.R. Bard, Inc. · Jul 1985
J & J ULCER DRESSING
K850451 · Johnson & Johnson Professionals, Inc. · Jun 1985
BARD ABSORPTION DRESSING
K831710 · C.R. Bard, Inc. · Jan 1984