Cleared Traditional

K934697 - MICROVASIVE MAXFORCE

K934697 is the FDA 510(k) clearance for MICROVASIVE MAXFORCE by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code KNQ) cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K934697 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
228d
Days
Class 2
Risk

K934697 is an FDA 510(k) clearance for the MICROVASIVE MAXFORCE. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on May 16, 1994 after a review of 228 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 K934697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1993
Decision Date May 16, 1994
Days to Decision 228 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
98d slower than avg
Panel avg: 130d · This submission: 228d
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 K934697.
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
OLYMPUS SCLEROTHERAPY BALLOON
K933992 · Olympus Corp. · Dec 1993
WILSON-COOK BALLOON DILATION CATHETERS
K900924 · Wilson-Cook Medical, Inc. · Dec 1990
SAVARY-GILLIARD DILATOR
K851955 · Wilson-Cook Medical, Inc. · Jul 1985