K132535

Substantially Equivalent

AUTOBAND LIGATOR

Applicant: Endochoice, Inc.
Product code: MND
Advisory panel: Gastroenterology, Urology
Date received: 2013-08-13
Decision date: 2013-08-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Alpharetta, GA, US

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.