AUTOBAND LIGATOR— 510(k) K132535

Name: FDA 510(k) clearance K132535
Creator: U.S. Food and Drug Administration
Published: 2013-08-23

Substantially Equivalent

Endochoice, Inc.

FDA 510(k) clearance K132535 for AUTOBAND LIGATOR, Substantially Equivalent on 2013-08-23. Applicant: Endochoice, Inc.. Device class: 2.

Clearance details

Applicant: Endochoice, Inc.
Product code: Code MND
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2013-08-13
Decision date: 2013-08-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MND

view all

K083556 — MODIFICATION TO AUTO-BAND LIGATOR2009-02-19
K081142 — AUTO-BAND LIGATOR2008-05-16
K051950 — INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN233212005-10-07
K031236 — AUTO-BAND LIGATOR2003-11-14
K033245 — BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U2003-11-06

More clearances from Endochoice, Inc.

view all

K160275 — Fuse Endoscopic System with FuseBox Processor2016-08-01
K161482 — EndoChoice Water Bottle Cap Irrigation System2016-06-27
K161167 — Seal Single-Use Biopsy Valve2016-05-26
K160403 — SmartStart Air/Water and Suction Valves2016-05-19
K153588 — EndoChoice Water Bottle Cap System2016-02-24

Adverse events under product code MND

product code MND

Death: 6
Injury: 255
Malfunction: 4,495
Total: 4,756

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.