Cleared Traditional

K971615 - PATTISON ESOPHAGEAL DILATOR

K971615 is the FDA 510(k) clearance for PATTISON ESOPHAGEAL DILATOR by Tri-Med Specialties, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNQ) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K971615 · Tri-Med Specialties, Inc. · Gastroenterology & Urology device
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Jul 1997
Decision
83d
Days
Class 2
Risk

K971615 is an FDA 510(k) clearance for the PATTISON ESOPHAGEAL DILATOR. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Tri-Med Specialties, Inc. (Lenexa, US). The FDA issued a Cleared decision on July 24, 1997 after a review of 83 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 Tri-Med Specialties, Inc. devices

Submission Details

510(k) Number K971615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1997
Decision Date July 24, 1997
Days to Decision 83 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 130d · This submission: 83d
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 20
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K971615.
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
K993720 · Cordis Corp. · Jan 2000
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
XXL BALLOON DILATATION CATHETER
K952656 · Boston Scientific Corp · Jul 1995
OVER THE GUIDEWIRE DILATATION SYSTEM
K924646 · Medovations, Inc. · Dec 1994