Cleared Traditional

K934675 - METAL URETERAL BASKET STONE DISLODGER

K934675 is an FDA 510(k) clearance for METAL URETERAL BASKET STONE DISLODGER, manufactured by Annex Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFL cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K934675 · Annex Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
101d
Days
Class 2
Risk

K934675 is an FDA 510(k) clearance for the METAL URETERAL BASKET STONE DISLODGER. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 101 days - within the typical 510(k) review window.

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 Annex Medical, Inc. devices

FDA 510(k) Submission Details - K934675

510(k) Number K934675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1993
Decision Date January 07, 1994
Days to Decision 101 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
29d faster than avg
Panel avg: 130d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFL Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K934675.
STONE EXTRACTOR, GRASPING FORCEPS
K935737 · Boston Scientific Corp · Sep 1994
STONE EXTRACTOR
K935721 · Boston Scientific Corp · Aug 1994
HELICAL STONE/FLATWIRE STONE BASKETS
K933260 · Surgitek · Jan 1994
BARD 4-WIRE URETEROSCOPIC STONE
K921233 · C.R. Bard, Inc. · Apr 1992
CANDELA STONE BASKETS
K884738 · Candela Laser Corp. · Feb 1989
VAN-TEC REUSABLE HELICAL STONE BASKET
K871777 · Van-Tec, Inc. · Jun 1987