510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K192346Substantially Equivalent

scaffolene CL100 Bioresorbable Collagen Matrix

Freudenberg Technology Innovation SE & Co. KG, Weinheim, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192346 is the FDA 510(k) clearance record for scaffolene CL100 Bioresorbable Collagen Matrix, cleared for Freudenberg Technology Innovation SE & Co. KG on under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)). FDA records list one 510(k) clearance for Freudenberg Technology Innovation SE & Co. KG. As of , FDA records show no recalls naming K192346.

Clearance record

Decision date
Received
(183 days to decision)
Product code
KGN Wound Dressing With Animal-Derived Material(S)
Device class
Unclassified
Review panel
Unknown
Applicant
Freudenberg Technology Innovation SE & Co. KG Hoehnerweg 2-4, Weinheim, DE
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