Cleared Traditional

BILIARY STONE DISLODGER (K925559) - FDA 510(k) Clearance

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

K925559 · Annex Medical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 1992
Decision
44d
Days
Class 2
Risk

K925559 is an FDA 510(k) clearance for the BILIARY STONE DISLODGER. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 17, 1992 after a review of 44 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Annex Medical, Inc. devices

Submission Details

510(k) Number K925559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date December 17, 1992
Days to Decision 44 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 130d · This submission: 44d
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 K925559.
ENDOSCOPIC BILIARY CATHETER
K946358 · Boston Scientific Corp · Apr 1995
MICROVASIVE INSURG FLAT WIRE BASKETS
K925879 · Boston Scientific Corp · Feb 1993
MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS
K925495 · Boston Scientific Corp · Dec 1992
WITTICH NITINOL STONE BASKET
K902944 · Cook, Inc. · Sep 1990
COPE NITINOL STONE BASKET
K902945 · Cook, Inc. · Sep 1990