Cleared Traditional

K965067 - DILATION CATHETER, BALLOON

K965067 is an FDA 510(k) clearance for DILATION CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K965067 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
41d
Days
Class 2
Risk

K965067 is an FDA 510(k) clearance for the DILATION CATHETER, BALLOON. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on January 28, 1997 after a review of 41 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 Corp devices

FDA 510(k) Submission Details - K965067

510(k) Number K965067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1996
Decision Date January 28, 1997
Days to Decision 41 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
90d faster than avg
Panel avg: 131d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GBM Device Classification - Class 2, Special Controls

Product Code GBM Catheter, Urethral
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 - GBM Catheter, Urethral

All 60
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K965067.
UROLOGICAL CATHETER
K992137 · Apogee, Inc. · Sep 1999
READYCATH CATHETER
K973120 · Medical Technologies of Georgia · Feb 1998
PERSONAL CATHETER
K970704 · Rochester Medical Corp. · Mar 1997
ASTA-CATH
K961361 · A+ Products · Oct 1996
URI-CATH CATHETER
K941672 · Gesco Intl., Inc. · May 1994
WALTHER CATHETERS, MALE, FEMALE
K926369 · Thomasville Medical Assoc. · May 1993