510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840172Substantially Equivalent

Ventral Wall Defect Reduct Silo

American Heyer Schulte, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840172 is the FDA 510(k) clearance record for VENTRAL WALL DEFECT REDUCT SILO, a class II device, cleared for American Heyer Schulte on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list 13 510(k) clearances for American Heyer Schulte, from to . As of , FDA records show no recalls naming K840172.

Clearance record

Decision date
Received
(162 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
American Heyer Schulte 803 N. Front St. Suite 3, Mchenry IL
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