BRAVO PH MONITORING SYSTEM— 510(k) K002028
Substantially EquivalentEndonetics, Inc.
FDA 510(k) clearance K002028 for BRAVO PH MONITORING SYSTEM, Substantially Equivalent on 2000-09-29. Applicant: Endonetics, Inc.. Device class: 1.
Clearance details
- Applicant
- Endonetics, Inc.
- Product code
- Code FFT
- Device class
- Class 1
- Regulation
- 21 CFR 876.1400
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Gatos, CA, US
Recent devices under product code FFT
view allAdverse events under product code FFT
product code FFT- Injury
- 595
- Malfunction
- 2,175
- Other
- 1
- Total
- 2,771
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K002028
K-number listed on FDA's recall record- Z-1619-2016 — Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
- Z-1620-2016 — Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002028.
Data sourced from openFDA. This site is unofficial and independent of the FDA.