510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K963141Substantially Equivalent

Kugel Hernia Patch

Douglas Bueschel, Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963141 is the FDA 510(k) clearance record for KUGEL HERNIA PATCH, a class II device, cleared for Douglas Bueschel on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list one 510(k) clearance for Douglas Bueschel. As of , FDA records show no recalls naming K963141.

Clearance record

Decision date
Received
(59 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Douglas Bueschel 10 Via Alicia, Santa Barbara CA
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