Cleared Traditional

K926399 - CUTIFILM(R) FILM (FDA 510(k) Clearance)

K926399 · Beiersdorf, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 1993
Decision
329d
Days
-
Risk

K926399 is an FDA 510(k) clearance for the CUTIFILM(R) FILM. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on November 15, 1993 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K926399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date November 15, 1993
Days to Decision 329 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
215d slower than avg
Panel avg: 114d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -