Cleared Traditional

BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) (K113836) - FDA 510(k) Clearance

K113836 · Avery Dennison Belgie Bvba · General & Plastic Surgery device
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Sep 2012
Decision
271d
Days
-
Risk

K113836 is an FDA 510(k) clearance for the BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Avery Dennison Belgie Bvba (Chicago, US). The FDA issued a Cleared decision on September 24, 2012 after a review of 271 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 Avery Dennison Belgie Bvba devices

Submission Details

510(k) Number K113836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2011
Decision Date September 24, 2012
Days to Decision 271 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
156d slower than avg
Panel avg: 115d · This submission: 271d
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 K113836.
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K103793 · Smith & Nephew, Inc. · May 2011