Cleared Traditional

K946358 - ENDOSCOPIC BILIARY CATHETER

K946358 is the FDA 510(k) clearance for ENDOSCOPIC BILIARY CATHETER by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code LQR) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K946358 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
102d
Days
Class 2
Risk

K946358 is an FDA 510(k) clearance for the ENDOSCOPIC BILIARY CATHETER. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on April 11, 1995 after a review of 102 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 Boston Scientific Corp devices

Submission Details

510(k) Number K946358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1994
Decision Date April 11, 1995
Days to Decision 102 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
28d faster than avg
Panel avg: 130d · This submission: 102d
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 24
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