Cleared Traditional

K974541 - MODIFIED URETERAL INDWELLING CATHETER/S...

K974541 is the FDA 510(k) clearance for MODIFIED URETERAL INDWELLING CATHETER/S... by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FAD) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K974541 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
68d
Days
Class 2
Risk

K974541 is an FDA 510(k) clearance for the MODIFIED URETERAL INDWELLING CATHETER/STENT. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on February 9, 1998 after a review of 68 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 Boston Scientific Corp devices

Submission Details

510(k) Number K974541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1997
Decision Date February 09, 1998
Days to Decision 68 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 130d · This submission: 68d
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 74
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K974541.
DD URETERAL STENT, INTEGRAL STENT
K982974 · Rusch Intl. · Jul 1999
C-FLEX URETERAL STENTS
K991219 · Applied Medical Resources · Jun 1999
BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE
K983498 · C.R. Bard, Inc. · Dec 1998
SUBCUTANEOUS URINARY DIVERSON STENT SET
K961371 · Cook Urological, Inc. · Jul 1996
LESE STENTS SETS
K952513 · Cook Urological, Inc. · Jun 1996
AQ HYDROPHILIC STENT
K961446 · Cook Urological, Inc. · May 1996