Cleared Traditional

K983373 - IMPACT BALLOON DILATION CATHETER

K983373 is an FDA 510(k) clearance for IMPACT BALLOON DILATION CATHETER, manufactured by B. Braun/Mcgaw. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K983373 · B. Braun/Mcgaw · Gastroenterology & Urology device
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Jun 1999
Decision
271d
Days
Class 2
Risk

K983373 is an FDA 510(k) clearance for the IMPACT BALLOON DILATION CATHETER. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by B. Braun/Mcgaw (Bethlehem, US). The FDA issued a Cleared decision on June 22, 1999 after a review of 271 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 B. Braun/Mcgaw devices

FDA 510(k) Submission Details - K983373

510(k) Number K983373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1998
Decision Date June 22, 1999
Days to Decision 271 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
141d slower than avg
Panel avg: 130d · This submission: 271d
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 22
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K983373.
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
K023907 · Cordis Corp. · Dec 2002
MEDOVATIONS ESOPHAGEAL DILATOR
K002363 · Medovations, Inc. · Nov 2000
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