Cleared Traditional

K061787 - MAXFORCE TTS SINGLE-USE BALLOON DILATOR

K061787 is an FDA 510(k) clearance for MAXFORCE TTS SINGLE-USE BALLOON DILATOR, 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 87-day FDA review.

K061787 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
87d
Days
Class 2
Risk

K061787 is an FDA 510(k) clearance for the MAXFORCE TTS SINGLE-USE BALLOON DILATOR. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on September 21, 2006 after a review of 87 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.

FDA 510(k) Submission Details - K061787

510(k) Number K061787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2006
Decision Date September 21, 2006
Days to Decision 87 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
44d faster than avg
Panel avg: 131d · This submission: 87d
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 39
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K061787.
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
K090183 · Cook Endoscopy · Sep 2009
SMART DILATOR
K082995 · Safestitch Medical · Feb 2009
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
K061937 · Cook Endoscopy · Dec 2006
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
K060302 · Cordis Europa, N.V. · Apr 2006
INSCOPE 3-STAGE BALLOON DILATOR
K043605 · Cordis Europa, N.V. · Feb 2005
BARD ELIMINATOR PET BALLOON DILATORS
K033936 · C.R. Bard, Inc. · Jan 2004
K061787 · MAXFORCE TTS SINGLE-USE BALLOON DILATOR
Download PDF FDA Summary Boston Scientific Corp