510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K962925Substantially Equivalent

Olympus B-5/B-7 Seriesballoon Catheter

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

K962925 is the FDA 510(k) clearance record for OLYMPUS B-5/B-7 SERIESBALLOON CATHETER, a class II device, cleared for Olympus America, Inc. on under FDA product code FGE (Stents, Drains And Dilators For The Biliary Ducts). FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show 5 recalls naming K962925.

Clearance record

Decision date
Received
(88 days to decision)
Product code
FGE Stents, Drains And Dilators For The Biliary Ducts
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus America, Inc. Two Corporate Center Dr., Melville NY
510(k) summary
Statement
Third party review
No

Clearances, product code FGE

Trailing 12 months
10 clearances under product code FGE in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FGE, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20262
April 20262
May 20260
June 20261
July 20261
August 20260
September 20262
October 20260