Cleared Traditional

K131700 - SENSATION SHORT THROW

K131700 is the FDA 510(k) clearance for SENSATION SHORT THROW by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FDI) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K131700 · Boston Scientific Corp · Gastroenterology & Urology device
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Nov 2013
Decision
146d
Days
Class 2
Risk

K131700 is an FDA 510(k) clearance for the SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-.... 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 November 4, 2013 after a review of 146 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.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K131700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2013
Decision Date November 04, 2013
Days to Decision 146 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
16d slower than avg
Panel avg: 130d · This submission: 146d
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 36
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K131700.
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV
K140726 · Boston Scientific Corp · Jul 2014
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
K133987 · Boston Scientific Corporation · Jan 2014
MULTI-STAGE SNARE
K133513 · United States Endoscopy Group, Inc. · Dec 2013
ROTH NET RETRIEVER
K122462 · United States Endoscopy Group, Inc. · Sep 2012
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
K103611 · United States Endoscopy Group, Inc. · May 2011
ETHICON ENDO SURGERY ARTICULATING SNARE
K073288 · Ethicon Endo-Surgery, Inc. · Jun 2008