510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K040868Substantially Equivalent

Sepramesh Ip Bioresorbable Barrier - Permanent Mesh

Genzyme Corporation, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040868 is the FDA 510(k) clearance record for SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH, a class II device, cleared for Genzyme Corp. on under FDA product code FTM (Mesh, Surgical). FDA records list 33 510(k) clearances for Genzyme Corp., from to . As of , FDA records show no recalls naming K040868.

Clearance record

Decision date
Received
(63 days to decision)
Product code
FTM Mesh, Surgical
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 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