510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914497Substantially Equivalent

Biopsy Forceps

Surgitek Medical Engineering Corp., Racine WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914497 is the FDA 510(k) clearance record for BIOPSY FORCEPS, a class I device, cleared for Surgitek Medical Engineering Corp. on under FDA product code FCL (Forceps, Biopsy, Non-Electric). FDA records list 11 510(k) clearances for Surgitek Medical Engineering Corp., from to . As of , FDA records show no recalls naming K914497.

Clearance record

Decision date
Received
(87 days to decision)
Product code
FCL Forceps, Biopsy, Non-Electric
Regulation
21 CFR 876.1075
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Surgitek Medical Engineering Corp. 3037 Mt. Pleasant St., Racine WI
510(k) summary
Statement
Third party review
No

Clearances, product code FCL

Trailing 12 months

FDA records hold no clearances under product code FCL in the trailing twelve months.

FDA records show no clearances under product code FCL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260