BRAVO PH MONITORING SYSTEM AND ACCESSORIES
FDA 510(k) clearance K102543 · decided 2010-12-01
Clearance details
- K-number
- K102543
- Device name
- BRAVO PH MONITORING SYSTEM AND ACCESSORIES
- Applicant
- Given Imaging , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-03
- Decision date
- 2010-12-01
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- FFT
- Device class
- 1
- Regulation number
- 876.1400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Yoqneam, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SANDHILL SCIENTIFIC PEDIATEC PH PROBE (K013951) | Sandhill Scientific, Inc. | 2002-02-28 |
| BRAVO PH MONITORING SYSTEM (K002028) | Endonetics, Inc. | 2000-09-29 |
| PH ANALYSIS MODULE (K961346) | Synectics-Dantec | 1997-01-29 |
| LOT 440 (K950087) | Medical Instruments Corporation Mic AG | 1996-02-06 |
| TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR (K955018) | Instrumentarium Corp. | 1996-01-30 |
| FLEXILOG 2000 (K945069) | Oakfield Instruments, Ltd. | 1995-06-13 |
| TRIP CIC CATHETER (K920849) | Tonometrics, Inc. | 1995-03-17 |
| CYBERRX MODEL 7200 (K934434) | Cybermed Control Systems, Inc. | 1995-01-24 |
| ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (K925405) | Synectics-Dantec | 1994-09-30 |
| SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (K931963) | Sandhill Scientific, Inc. | 1994-09-28 |
| MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION (K913817) | Synectics-Dantec | 1992-06-11 |
| PH METER, MODIFICATION (K914624) | Synectics-Dantec | 1992-04-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to recall (Z-2047-2025) | Given Imaging Ltd. | 2025-07-10 |
| Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 031 recall (Z-0966-2012) | Given Imaging Ltd. | 2012-02-06 |