Cleared Traditional

K854652 - ANGIOMED URETERAL STONE DISLODGERS

K854652 is the FDA 510(k) clearance for ANGIOMED URETERAL STONE DISLODGERS by Angiomed U.S., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FFL) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K854652 · Angiomed U.S., Inc. · Gastroenterology & Urology device
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Feb 1986
Decision
83d
Days
Class 2
Risk

K854652 is an FDA 510(k) clearance for the ANGIOMED URETERAL STONE DISLODGERS. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on February 10, 1986 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - 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 Angiomed U.S., Inc. devices

Submission Details

510(k) Number K854652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1985
Decision Date February 10, 1986
Days to Decision 83 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 130d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFL Dislodger, Stone, Basket, Ureteral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
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 - FFL Dislodger, Stone, Basket, Ureteral, Metal

All 26
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K854652.
DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETER
K860946 · Van-Tec, Inc. · Apr 1986
VAN-TEC DEFLECTING LOOP RETRIEVER
K860269 · Van-Tec, Inc. · Mar 1986
VAN-TEC DEFLECTING ROTATING SEGURA BASKET
K860270 · Van-Tec, Inc. · Mar 1986
WILSON-COOK STONE EXTRACTOR
K851965 · Wilson-Cook Medical, Inc. · Jul 1985
URETERAL DILATOR & URETERAL STONE DISLODGER
K850954 · American Edwards Laboratories · Apr 1985
SEGURA BASKET
K841942 · Van-Tec, Inc. · Jul 1984