Cleared Traditional

Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)

K250409 · Olympus Medical Systems Corporation · Gastroenterology & Urology
Oct 2025
Decision
250d
Days
Class 2
Risk

About This 510(k) Submission

K250409 is an FDA 510(k) clearance for the Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA), a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Olympus Medical Systems Corporation (Hachiochi-Shi, JP). The FDA issued a Cleared decision on October 21, 2025, 250 days after receiving the submission on February 13, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.

Submission Details

510(k) Number K250409 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2025
Decision Date October 21, 2025
Days to Decision 250 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FGE — Stents, Drains And Dilators For The Biliary Ducts
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5010

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