Cleared Traditional

K885279 - CUTINOVA PLUS ON VASCULAR STASIS ULCERS

K885279 · Beiersdorf, Inc. · General & Plastic Surgery device
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Jun 1989
Decision
172d
Days
-
Risk

K885279 is an FDA 510(k) clearance for the CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on June 13, 1989 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

FDA 510(k) Submission Details - K885279

510(k) Number K885279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1988
Decision Date June 13, 1989
Days to Decision 172 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
57d slower than avg
Panel avg: 115d · This submission: 172d
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
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WOUND TREATMENT KIT
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K892360 · Pfizer, Inc. · Jun 1989
ACTIDERM*-OPAQUE
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