Cleared Traditional

K103648 - COLLAGEN POWDER

K103648 · Innocoll Pharmaceuticals, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
274d
Days
-
Risk

K103648 is an FDA 510(k) clearance for the COLLAGEN POWDER. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Innocoll Pharmaceuticals, Ltd. (Athlone, Co. Westmeath, IE). The FDA issued a Cleared decision on September 14, 2011 after a review of 274 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 Innocoll Pharmaceuticals, Ltd. devices

FDA 510(k) Submission Details - K103648

510(k) Number K103648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2010
Decision Date September 14, 2011
Days to Decision 274 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
159d slower than avg
Panel avg: 115d · This submission: 274d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 119
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K103648.
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