Cleared Traditional

K133750 - OCCLUDER OCCLUSION BALLOON CATHETER

K133750 is the FDA 510(k) clearance for OCCLUDER OCCLUSION BALLOON CATHETER by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code EYB) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K133750 · Boston Scientific Corporation · Gastroenterology & Urology device
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Jan 2014
Decision
30d
Days
Class 2
Risk

K133750 is an FDA 510(k) clearance for the OCCLUDER OCCLUSION BALLOON CATHETER. Classified as Catheter, Ureteral, Gastro-urology (product code EYB), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on January 8, 2014 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Corporation devices

Submission Details

510(k) Number K133750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2013
Decision Date January 08, 2014
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EYB Catheter, Ureteral, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - EYB Catheter, Ureteral, Gastro-urology

All 18
Devices cleared under the same product code (EYB) and FDA review panel - the closest regulatory comparables to K133750.
Ureteric Catheters
K182122 · Coloplast Corp. · Oct 2018
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
K180182 · Cook Incorporated · Sep 2018
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
K171043 · Coloplast Corp. · Dec 2017
MEDLINE RED RUBBER URETHRAL CATHETER
K092250 · Medline Industries, Inc. · Jan 2010
BARD DUAL LUMEN URETERAL CATHETER
K032521 · C.R. Bard, Inc. · Nov 2003
APPLIED URETERAL CATHETER
K020577 · Applied Medical Resources Corp. · May 2002