Cleared Traditional

K092805 - COLLAGEN SPONGE

K092805 · Innocoll Pharmaceuticals · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
158d
Days
-
Risk

K092805 is an FDA 510(k) clearance for the COLLAGEN SPONGE. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Innocoll Pharmaceuticals (Athlone, Co. Westmeath, IE). The FDA issued a Cleared decision on February 16, 2010 after a review of 158 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.

FDA 510(k) Submission Details - K092805

510(k) Number K092805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2009
Decision Date February 16, 2010
Days to Decision 158 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 115d · This submission: 158d
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 184
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K092805.
SURGIAID
K100927 · Maxigen Biotech, Inc. · Feb 2011
COLLEXA
K100574 · Innocoll Pharmaceuticals · Oct 2010
ENDOFORM DENTAL TEMPLATE
K101546 · Mesynthes, Ltd. · Jun 2010
ENDOFORM DERMAL TEMPLATE
K092096 · Mesynthes, Ltd. · Jan 2010
ACELL MATRISTEM WOUND SHEET
K092926 · Acell, Inc. · Oct 2009
THERAFORM BILAYER
K090823 · Sewon Cellontech Co., Ltd. · Oct 2009
K092805 · COLLAGEN SPONGE
Download PDF FDA Summary Innocoll Pharmaceutic…