Cleared Traditional

REPROCESSED STONE RETRIEVAL BASKETS (K012581) - FDA 510(k) Clearance

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

K012581 · Sterilmed, Inc. · Gastroenterology & Urology device
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Feb 2002
Decision
189d
Days
Class 2
Risk

K012581 is an FDA 510(k) clearance for the REPROCESSED STONE RETRIEVAL BASKETS. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on February 14, 2002 after a review of 189 days - an extended review 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: 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 Sterilmed, Inc. devices

Submission Details

510(k) Number K012581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2001
Decision Date February 14, 2002
Days to Decision 189 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
59d slower than avg
Panel avg: 130d · This submission: 189d
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

Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K012581.
Peralta Stone Removal Catheter
K190492 · Calcula Technologies, Inc. · Jul 2019
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS
K961248 · C.R. Bard, Inc. · May 1996
STONE EXTRACTOR, GRASPING FORCEPS
K935737 · Boston Scientific Corp · Sep 1994
STONE EXTRACTOR
K935721 · Boston Scientific Corp · Aug 1994
BARD 4-WIRE URETEROSCOPIC STONE
K921233 · C.R. Bard, Inc. · Apr 1992