510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K943304Substantially Equivalent

3D Surgical Endoscopy System for Urology

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

K943304 is the FDA 510(k) clearance record for 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY, a class II device, cleared for Olympus America, Inc. on under FDA product code FCG (Biopsy Needle). FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show no recalls naming K943304.

Clearance record

Decision date
Received
(530 days to decision)
Product code
FCG Biopsy Needle
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus America, Inc. 4 Nevada Dr., Lake Success NY
510(k) summary
Summary
Third party review
No

Clearances, product code FCG

Trailing 12 months

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

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