510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K090823Substantially Equivalent

Theraform Bilayer

Sewon Cellontech Co., Ltd., Santa Fe Springs CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090823 is the FDA 510(k) clearance record for THERAFORM BILAYER, cleared for Sewon Cellontech Co., Ltd. on under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)). FDA records list 2 510(k) clearances for Sewon Cellontech Co., Ltd., from to . As of , FDA records show no recalls naming K090823.

Clearance record

Decision date
Received
(210 days to decision)
Product code
KGN Wound Dressing With Animal-Derived Material(S)
Device class
Unclassified
Review panel
Unknown
Applicant
Sewon Cellontech Co., Ltd. 13340 E Firestone Blvd., Santa Fe Springs CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KGN

Trailing 12 months
16 clearances under product code KGN in the twelve months to October 2026, June 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code KGN, trailing twelve months
MonthClearances
November 20250
December 20253
January 20261
February 20262
March 20261
April 20260
May 20261
June 20265
July 20261
August 20261
September 20261
October 20260