510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934186Substantially Equivalent

Forceps, Biopsy, Gastrointestinal

Primed Instruments, Inc., M9c 4h3, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934186 is the FDA 510(k) clearance record for FORCEPS, BIOPSY, GASTROINTESTINAL, a class I device, cleared for Primed Instruments, Inc. on under FDA product code FCL (Forceps, Biopsy, Non-Electric). FDA records list one 510(k) clearance for Primed Instruments, Inc. As of , FDA records show no recalls naming K934186.

Clearance record

Decision date
Received
(110 days to decision)
Product code
FCL Forceps, Biopsy, Non-Electric
Regulation
21 CFR 876.1075
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Primed Instruments, Inc. 17 Oxenden Crescent, M9c 4h3, CA
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