Cleared Traditional

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 (K091495) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091495 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2009
Decision
106d
Days
Class 2
Risk

K091495 is an FDA 510(k) clearance for the SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-.... Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on September 3, 2009 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K091495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2009
Decision Date September 03, 2009
Days to Decision 106 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 130d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LQR Dislodger, Stone, Biliary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LQR Dislodger, Stone, Biliary

All 37
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