Cleared Traditional

SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES

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

About This 510(k) Submission

K131700 is an FDA 510(k) clearance for the SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Boston Scientific Corp (Marborough, US). The FDA issued a Cleared decision on November 4, 2013, 146 days after receiving the submission on June 11, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K131700 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FDI — Snare, Flexible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

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