WATER BOTTLE CAP IRRIGATON SYSTEM— 510(k) K120862

Substantially Equivalent

Endochoice, Inc.

FDA 510(k) clearance K120862 for WATER BOTTLE CAP IRRIGATON SYSTEM, Substantially Equivalent on 2012-11-27. Applicant: Endochoice, Inc..

Clearance details

Applicant: Endochoice, Inc.
Product code: Code FEQ
Advisory panel: Gastroenterology, Urology
Date received: 2012-03-22
Decision date: 2012-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

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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.