Cleared Special

AUTOBAND LIGATOR

K132535 · Endochoice, Inc. · Gastroenterology & Urology
Aug 2013
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K132535 is an FDA 510(k) clearance for the AUTOBAND LIGATOR, a Ligator, Esophageal (Class II — Special Controls, product code MND), submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on August 23, 2013, 10 days after receiving the submission on August 13, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.

Submission Details

510(k) Number K132535 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2013
Decision Date August 23, 2013
Days to Decision 10 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MND — Ligator, Esophageal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4400

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