Cleared Traditional

K243807 - Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P (FDA 510(k) Clearance)

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

K243807 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
97d
Days
Class 2
Risk

K243807 is an FDA 510(k) clearance for the Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachiochi-Shi, JP). The FDA issued a Cleared decision on March 18, 2025 after a review of 97 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 Corp. devices

Submission Details

510(k) Number K243807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2024
Decision Date March 18, 2025
Days to Decision 97 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 130d · This submission: 97d
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 Consultant

Olympus Corporation of the Americas
Roshana Ahmed

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LQR Dislodger, Stone, Biliary

All 37
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K243807.
Disposable Stone Extraction Basket
K253056 · Zhejiang Soudon Medical Technology Co., Ltd. · Apr 2026
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K243471 · Micro-Tech (Nanjing) Co., Ltd. · Dec 2024
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K240192 · Scivita Medical Technology Co., Ltd. · Oct 2024
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K203322 · Boston Scientific Corporation · May 2021