Cleared Traditional

DISLODGER, STONE, BASKET, URETERAL, METAL (K924027) - FDA 510(k) Clearance

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

K924027 · Annex Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
70d
Days
Class 2
Risk

K924027 is an FDA 510(k) clearance for the DISLODGER, STONE, BASKET, URETERAL, METAL. 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 October 20, 1992 after a review of 70 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 Annex Medical, Inc. devices

Submission Details

510(k) Number K924027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1992
Decision Date October 20, 1992
Days to Decision 70 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
60d faster than avg
Panel avg: 130d · This submission: 70d
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 K924027.
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