Cleared Traditional

AM CATH ESWL STENT (K864669) - FDA 510(k) Clearance

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

K864669 · Inter-Med Corp. · Gastroenterology & Urology device
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Jan 1987
Decision
34d
Days
Class 2
Risk

K864669 is an FDA 510(k) clearance for the AM CATH ESWL STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Inter-Med Corp. (Danielson, US). The FDA issued a Cleared decision on January 5, 1987 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - 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 Inter-Med Corp. devices

Submission Details

510(k) Number K864669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1986
Decision Date January 05, 1987
Days to Decision 34 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
96d faster than avg
Panel avg: 130d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
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 - FAD Stent, Ureteral

All 47
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K864669.
MODIFIED URETERAL INDWELLING CATHETER/STENT
K974541 · Boston Scientific Corp · Feb 1998
BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
K903345 · C.R. Bard, Inc. · Apr 1991
BARD(R) URETERAL STENT W/SUTURE
K883561 · C.R. Bard, Inc. · Nov 1988
BARD DOUBLE PIGTAIL URETERAL STENT
K861478 · C.R. Bard, Inc. · May 1986
BARD URETERAL STENT
K823487 · C.R. Bard, Inc. · May 1983