510(k) K112576— ENDOCHOICE WATER BOTTLE CAP SYSTEM

Substantially Equivalent

Endochoice, Inc.

Clearance details

Applicant: Endochoice, Inc.
Product code: Code FEQ
Advisory panel: Gastroenterology, Urology
Date received: 2011-09-06
Decision date: 2012-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Adverse events under product code FEQ

product code FEQ

Malfunction: 1,135
Total: 1,135

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.