510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962474Substantially Equivalent

Olympus Fg Series of Rat Tooth Grasping Forceps (Urology)

OLYMPUS Corporation of the Americas, Melville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962474 is the FDA 510(k) clearance record for OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY), a class II device, cleared for Olympus America, Inc. on under FDA product code FBO (Cystourethroscope). FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show no recalls naming K962474.

Clearance record

Decision date
Received
(178 days to decision)
Product code
FBO Cystourethroscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus America, Inc. Two Corporate Center Dr., Melville NY
510(k) summary
Summary
Third party review
No

Clearances, product code FBO

Trailing 12 months

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

FDA records show no clearances under product code FBO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FBO, 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