Cleared Traditional

K891254 - UROLOGICAL STONE BASKET

K891254 is the FDA 510(k) clearance for UROLOGICAL STONE BASKET by Northgate Research, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FFL) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K891254 · Northgate Research, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
14d
Days
Class 2
Risk

K891254 is an FDA 510(k) clearance for the UROLOGICAL STONE BASKET. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Northgate Research, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on March 22, 1989 after a review of 14 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 Northgate Research, Inc. devices

Submission Details

510(k) Number K891254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1989
Decision Date March 22, 1989
Days to Decision 14 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
116d faster than avg
Panel avg: 130d · This submission: 14d
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 27
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K891254.
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
HELICAL STONE BASKET (DISPOSABLE)
K871779 · Van-Tec, Inc. · Jun 1987