510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945377Substantially Equivalent

Trelex Natural(r) Mesh

Meadox Medicals, Div. Boston Scientific Corp., Oakland NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945377 is the FDA 510(k) clearance record for TRELEX NATURAL(R) MESH, a class II device, cleared for Meadox Medicals, Div. Boston Scientific Corp. on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list 53 510(k) clearances for Meadox Medicals, Div. Boston Scientific Corp., from to . As of , FDA records show no recalls naming K945377.

Clearance record

Decision date
Received
(45 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Meadox Medicals, Div. Boston Scientific Corp. 112 Bauer Dr., Oakland NJ
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