510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994328Substantially Equivalent

Sepramesh Biosurgical Composite, Model Smbc-Xxx

Genzyme Corporation, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994328 is the FDA 510(k) clearance record for SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX, a class II device, cleared for Genzyme Corp. on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list 33 510(k) clearances for Genzyme Corp., from to . As of , FDA records show no recalls naming K994328.

Clearance record

Decision date
Received
(71 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Genzyme Corp. 500 Kendall St., Cambridge MA
510(k) summary
Summary
Third party review
No

Clearances, product code FTL

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