Cleared Traditional

K864913 - CUTINOVA PLUS FOAM GELFILM

K864913 · Beiersdorf, Inc. · General & Plastic Surgery device
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Jul 1987
Decision
220d
Days
-
Risk

K864913 is an FDA 510(k) clearance for the CUTINOVA(R) PLUS FOAM GELFILM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on July 24, 1987 after a review of 220 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

FDA 510(k) Submission Details - K864913

510(k) Number K864913 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 16, 1986
Decision Date July 24, 1987
Days to Decision 220 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
105d slower than avg
Panel avg: 115d · This submission: 220d
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 226
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K864913.
DERMATOLOGICAL PATCH
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INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987
AMERICAN PHARMASEAL WOUND DRESSING
K871770 · American Pharmaseal Div. Ahsc · Jun 1987
VISCOPASTE ZINC PASTE BANDAGE
K863930 · Smith & Nephew, Inc. · Dec 1986
LYOFOAM C ODOR-ABSORBING DRESSING
K864084 · Acme United Corp. · Nov 1986