Cleared Traditional

Nathanson Transcystic Bile Duct Stone Exploration Pack (K171915) - FDA 510(k) Clearance

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

K171915 · Cook Incorporated · Gastroenterology & Urology device
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Mar 2018
Decision
248d
Days
Class 2
Risk

K171915 is an FDA 510(k) clearance for the Nathanson Transcystic Bile Duct Stone Exploration Pack. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on March 1, 2018 after a review of 248 days - an extended review cycle.

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 Cook Incorporated devices

Submission Details

510(k) Number K171915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2017
Decision Date March 01, 2018
Days to Decision 248 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
118d slower than avg
Panel avg: 130d · This submission: 248d
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 22
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K171915.
Stonetome Stone Removal Device
K191789 · Boston Scientific Corporation · Jul 2019
Wilson-Cook Mini Basket
K182381 · Wilson-Cook Medical, Inc. · Oct 2018
Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket
K171969 · Wilson-Cook Medical, Inc. · Mar 2018
Strange Bile Duct Stone Exploration Set
K173687 · Cook Incorporated · Dec 2017
Wittich Nitinol Stone Basket
K170898 · Cook Incorporated · Dec 2017
Single Use Retrieval Nitinol Basket V
K170811 · Olympus Medical Systems Corp. · Nov 2017