510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132025Substantially Equivalent

Meso Bilayer Surgical Mesh

Kensey Nash Corporation dba Dsm Biomedical, Exton PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132025 is the FDA 510(k) clearance record for MESO BILAYER SURGICAL MESH, a class II device, cleared for Kensey Nash Corporation Dba Dsm Biomedical on under FDA product code FTM (Mesh, Surgical). FDA records list 7 510(k) clearances for Kensey Nash Corporation Dba Dsm Biomedical, from to . As of , FDA records show no recalls naming K132025.

Clearance record

Decision date
Received
(121 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kensey Nash Corporation Dba Dsm Biomedical 735 Pennsylvania Dr., Exton PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTM

Trailing 12 months
1 clearance under product code FTM in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FTM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260