Cleared Traditional

HELI-TECH RETRIEVAL BASKET (K926040) - FDA 510(k) Clearance

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

K926040 · Cape Tech Medical Products · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
22d
Days
Class 2
Risk

K926040 is an FDA 510(k) clearance for the HELI-TECH RETRIEVAL BASKET. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Cape Tech Medical Products (Falmouth, US). The FDA issued a Cleared decision on December 23, 1992 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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 Cape Tech Medical Products devices

Submission Details

510(k) Number K926040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date December 23, 1992
Days to Decision 22 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
108d faster than avg
Panel avg: 130d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LQR Dislodger, Stone, Biliary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - LQR Dislodger, Stone, Biliary

All 22
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K926040.
ENDOSCOPIC BILIARY CATHETER
K946358 · Boston Scientific Corp · Apr 1995
MICROVASIVE INSURG FLAT WIRE BASKETS
K925879 · Boston Scientific Corp · Feb 1993
MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS
K925495 · Boston Scientific Corp · Dec 1992
WITTICH NITINOL STONE BASKET
K902944 · Cook, Inc. · Sep 1990
COPE NITINOL STONE BASKET
K902945 · Cook, Inc. · Sep 1990