Cleared Traditional

K915538 - OVER THE WIRE STONE BASKET (FDA 510(k) Clearance)

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

K915538 · Medical Dynamics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
101d
Days
Class 2
Risk

K915538 is an FDA 510(k) clearance for the OVER THE WIRE STONE BASKET. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Medical Dynamics, Inc. (Englewood, US). The FDA issued a Cleared decision on March 20, 1992 after a review of 101 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 Medical Dynamics, Inc. devices

Submission Details

510(k) Number K915538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1991
Decision Date March 20, 1992
Days to Decision 101 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 130d · This submission: 101d
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
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K915538.
Disposable Stone Extraction Basket
K253056 · Zhejiang Soudon Medical Technology Co., Ltd. · Apr 2026
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
K243807 · Olympus Medical Systems Corp. · Mar 2025
Extraction Basket
K243471 · Micro-Tech (Nanjing) Co., Ltd. · Dec 2024
Single-use Extraction Baskets
K240192 · Scivita Medical Technology Co., Ltd. · Oct 2024
Stone Extraction Baskets
K230598 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Sep 2023
SpyGlass Discover Retrieval Basket
K203322 · Boston Scientific Corporation · May 2021