Cleared Traditional

K140726 - CAPTIVATOR EMR DEVICE FOR STANDARD GAST...

K140726 is the FDA 510(k) clearance for CAPTIVATOR EMR DEVICE FOR STANDARD GAST... by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FDI) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K140726 · Boston Scientific Corp · Gastroenterology & Urology device
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Jul 2014
Decision
119d
Days
Class 2
Risk

K140726 is an FDA 510(k) clearance for the CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVIC.... Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on July 21, 2014 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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.

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Submission Details

510(k) Number K140726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2014
Decision Date July 21, 2014
Days to Decision 119 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
11d faster than avg
Panel avg: 130d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDI Snare, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - FDI Snare, Flexible

All 35
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K140726.
Single Use Electrosurgical Snare SD-400
K172734 · Olympus Medical Systems Corp. · Dec 2017
Rotatable Snares
K160637 · Boston Scientific Corporation · Mar 2016
Lariat snare
K151197 · United States Endoscopy Group, Inc. · Jul 2015
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
K133987 · Boston Scientific Corporation · Jan 2014
MULTI-STAGE SNARE
K133513 · United States Endoscopy Group, Inc. · Dec 2013
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
K131700 · Boston Scientific Corp · Nov 2013