Cleared Traditional

K090823 - THERAFORM BILAYER

K090823 · Sewon Cellontech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
210d
Days
-
Risk

K090823 is an FDA 510(k) clearance for the THERAFORM BILAYER. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Sewon Cellontech Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on October 22, 2009 after a review of 210 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 - K090823

510(k) Number K090823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2009
Decision Date October 22, 2009
Days to Decision 210 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
95d slower than avg
Panel avg: 115d · This submission: 210d
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 188
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K090823.
COLLAGEN SPONGE
K092805 · Innocoll Pharmaceuticals · Feb 2010
ENDOFORM DERMAL TEMPLATE
K092096 · Mesynthes, Ltd. · Jan 2010
ACELL MATRISTEM WOUND SHEET
K092926 · Acell, Inc. · Oct 2009
COLLASORB COLLAGEN WOUND DRESSING
K091338 · Hartmann-Conco, Inc. · Aug 2009
THERAFORM STANDARD/SHEET
K090812 · Sewon Cellontech Co., Ltd. · Jul 2009
ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc · Jul 2009
K090823 · THERAFORM BILAYER
Download PDF FDA Summary Sewon Cellontech Co.,…