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
K142887Substantially Equivalent

SIS Inguinal Hernia Repair Graft

Cook Biotech Incorprated, West Lafayette IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142887 is the FDA 510(k) clearance record for SIS Inguinal Hernia Repair Graft, a class II device, cleared for Cook Biotech Incorprated on under FDA product code FTM (Mesh, Surgical). FDA records list 4 510(k) clearances for Cook Biotech Incorprated, from to . As of , FDA records show no recalls naming K142887.

Clearance record

Decision date
Received
(364 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cook Biotech Incorprated 1425 Innovation Pl., West Lafayette IN
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