Cleared Traditional

CUTINOVA(R) PLUS FOAM GELFILM (K864913) - FDA 510(k) Clearance

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

Submission Details

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
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 115d · This submission: 220d
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 K864913.
TEGASORB ULCER DRESSING #90-XXX
K872298 · 3M Company · Apr 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
K881048 · Smith & Nephew, Inc. · Mar 1988
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987
VISCOPASTE ZINC PASTE BANDAGE
K863930 · Smith & Nephew, Inc. · Dec 1986
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS
K862163 · Johnson & Johnson Professionals, Inc. · Jul 1986
NON-ADHERING DRESSING WITH POVIDONE-IODINE
K861384 · Johnson & Johnson Professionals, Inc. · Jul 1986