Cleared Traditional

Single Use Retrieval Nitinol Basket V (K170811) - FDA 510(k) Clearance

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

K170811 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Nov 2017
Decision
255d
Days
Class 2
Risk

K170811 is an FDA 510(k) clearance for the Single Use Retrieval Nitinol Basket V. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on November 27, 2017 after a review of 255 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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K170811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2017
Decision Date November 27, 2017
Days to Decision 255 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
125d slower than avg
Panel avg: 130d · This submission: 255d
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
Sheri L. Musgnung

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 22
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K170811.
Nathanson Transcystic Bile Duct Stone Exploration Pack
K171915 · Cook Incorporated · Mar 2018
Strange Bile Duct Stone Exploration Set
K173687 · Cook Incorporated · Dec 2017
Wittich Nitinol Stone Basket
K170898 · Cook Incorporated · Dec 2017
NCompass Nitinol Stone Extractors
K173009 · Cook Incorporated · Nov 2017
SPYCATCH STONE RETRIEVAL BASKET
K071066 · Boston Scientific Corp · Jun 2007
KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS
K952149 · KARL STORZ Endoscopy-America, Inc. · Jun 1995