BRAVO PH MONITORING SYSTEM— 510(k) K002028

Substantially Equivalent

Endonetics, Inc.

FDA 510(k) clearance K002028 for BRAVO PH MONITORING SYSTEM, Substantially Equivalent on 2000-09-29. Applicant: Endonetics, Inc..

Clearance details

Applicant: Endonetics, Inc.
Product code: Code FFT
Advisory panel: Gastroenterology, Urology
Date received: 2000-07-03
Decision date: 2000-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Gatos, CA, US

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Adverse events under product code FFT

product code FFT

Injury: 595
Malfunction: 2,175
Other: 1
Total: 2,771

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.