510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040998Substantially Equivalent

Modification to Parietex Composite (Pco) Mesh

Sofradim Production, Ayer MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040998 is the FDA 510(k) clearance record for MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH, a class II device, cleared for Sofradim Production on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list 42 510(k) clearances for Sofradim Production, from to . As of , FDA records show no recalls naming K040998.

Clearance record

Decision date
Received
(10 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sofradim Production 5 Whitcomb Ave., Ayer MA
510(k) summary
Summary PDF
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