Cleared Traditional

K971320 - CRE BALLOON DILATATION CATHETER

K971320 is the FDA 510(k) clearance for CRE 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 182-day FDA review.

K971320 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
182d
Days
Class 2
Risk

K971320 is an FDA 510(k) clearance for the CRE 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 October 9, 1997 after a review of 182 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K971320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1997
Decision Date October 09, 1997
Days to Decision 182 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
52d slower than avg
Panel avg: 130d · This submission: 182d
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 K971320.
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
K023907 · Cordis Corp. · Dec 2002
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
K993720 · Cordis Corp. · Jan 2000
CRE(TM) BALLOON DILATATION CATHETER
K974788 · Boston Scientific Corp · Mar 1998
BALLON DILATATION CATHETER
K961438 · Boston Scientific Corp · Jul 1996
XXL BALLOON DILATATION CATHETER
K952656 · Boston Scientific Corp · Jul 1995
WILSON-COOK BALLOON INFLATION DEVICE
K933845 · Wilson-Cook Medical, Inc. · Nov 1994