Cleared Traditional

K965229 - IMAGER TORQUE CATHETER

K965229 is the FDA 510(k) clearance for IMAGER TORQUE CATHETER by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K965229 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
63d
Days
Class 2
Risk

K965229 is an FDA 510(k) clearance for the IMAGER TORQUE CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 4, 1997 after a review of 63 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

Submission Details

510(k) Number K965229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1996
Decision Date March 04, 1997
Days to Decision 63 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
67d faster than avg
Panel avg: 130d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
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 - KOD Catheter, Urological

All 115
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K965229.
INCARE INTERMITTENT CATHETER
K013345 · Hollister, Inc. · Jan 2002
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · Boston Scientific Corp · Jul 2001
FLOCATH
K000070 · Rusch Intl. · Feb 2000
URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
K951260 · Biosearch Medical Products, Inc. · Sep 1995
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
K922527 · C.R. Bard, Inc. · Apr 1994
PERCUTANEOUS DRAINAGE LOOP CATHETER SET
K931195 · Cook Urological, Inc. · Dec 1993