Cleared Traditional

K952656 - XXL BALLOON DILATATION CATHETER

K952656 is the FDA 510(k) clearance for XXL BALLOON DILATATION CATHETER by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code KNQ) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K952656 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
72d
Days
Class 2
Risk

K952656 is an FDA 510(k) clearance for the XXL BALLOON DILATATION CATHETER. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on July 19, 1995 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - 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 K952656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date July 19, 1995
Days to Decision 72 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
58d faster than avg
Panel avg: 130d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNQ Dilator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
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 - KNQ Dilator, Esophageal

All 15
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K952656.
CRE(TM) BALLOON DILATATION CATHETER
K974788 · Boston Scientific Corp · Mar 1998
CRE BALLOON DILATATION CATHETER
K971320 · Boston Scientific Corp · Oct 1997
BALLON DILATATION CATHETER
K961438 · Boston Scientific Corp · Jul 1996
WILSON-COOK BALLOON INFLATION DEVICE
K933845 · Wilson-Cook Medical, Inc. · Nov 1994
MICROVASIVE MAXFORCE
K934697 · Boston Scientific Corp · May 1994
OLYMPUS SCLEROTHERAPY BALLOON
K933992 · Olympus Corp. · Dec 1993