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
K973955Substantially Equivalent

Herniamesh Surgical Meshes

Herniamesh SRL, Omaha NE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973955 is the FDA 510(k) clearance record for HERNIAMESH SURGICAL MESHES, a class II device, cleared for Herniamesh on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list 4 510(k) clearances for Herniamesh, from to . As of , FDA records show no recalls naming K973955.

Clearance record

Decision date
Received
(207 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Herniamesh 1802 # 103 Ave., Omaha NE
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