510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K091495Substantially Equivalent

Single Use 3-Lumen Extraction Balloon V, Model V B-V233p-A,b-V233p-B,b-V433p-A,b-V433p-B, Bv243q-a, B-V243q-B, B-V443q-a

Olympus Medical Systems Corp., Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091495 is the FDA 510(k) clearance record for SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A, a class II device, cleared for Olympus Medical Systems Corporation on under FDA product code LQR (Dislodger, Stone, Biliary). FDA records list 186 510(k) clearances for Olympus Medical Systems Corporation, from to . As of , FDA records show 3 recalls naming K091495.

Clearance record

Decision date
Received
(106 days to decision)
Product code
LQR Dislodger, Stone, Biliary
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corporation 3500 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LQR

Trailing 12 months
1 clearance under product code LQR in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LQR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260