Cleared Traditional

K974788 - CRE(TM) BALLOON DILATATION CATHETER

K974788 is an FDA 510(k) clearance for CRE(TM) BALLOON DILATATION CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K974788 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
88d
Days
Class 2
Risk

K974788 is an FDA 510(k) clearance for the CRE(TM) 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 March 20, 1998 after a review of 88 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

FDA 510(k) Submission Details - K974788

510(k) Number K974788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1997
Decision Date March 20, 1998
Days to Decision 88 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
43d faster than avg
Panel avg: 131d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNQ Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K974788.
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
K993720 · Cordis Corp. · Jan 2000
IMPACT BALLOON DILATION CATHETER
K983373 · B. Braun/Mcgaw · Jun 1999
JACKSON ESOPHAGEAL DILATOR
K990935 · Pilling Weck Surgical · May 1999
CRE BALLOON DILATATION CATHETER
K971320 · Boston Scientific Corp · Oct 1997
PATTISON ESOPHAGEAL DILATOR
K971615 · Tri-Med Specialties, Inc. · Jul 1997
BALLON DILATATION CATHETER
K961438 · Boston Scientific Corp · Jul 1996