510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K974540Substantially Equivalent

Sis Hernia Repair Device

Sentron Medical, Inc., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974540 is the FDA 510(k) clearance record for SIS HERNIA REPAIR DEVICE, a class II device, cleared for Sentron Medical, Inc. on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list one 510(k) clearance for Sentron Medical, Inc. As of , FDA records show no recalls naming K974540.

Clearance record

Decision date
Received
(168 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sentron Medical, Inc. 4445 Lake Forest Dr., Cincinnati OH
510(k) summary
Summary
Third party review
No

Clearances, product code FTL

Trailing 12 months
2 clearances 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 20261
October 20260