Electrode, Ph, Stomach
FDA product code FFT · Class I (low risk) · 21 CFR 876.1400 · Gastroenterology, Urology
49510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Synectics-Dantec 10
- Sandhill Scientific, Inc. 4
- Diamond Medical, Inc. 4
- Tonometrics, Inc. 3
- Oakfield Instruments, Ltd. 2
- Biosearch Medical Products, Inc. 2
- Chemfet Corp. 2
- Sensatronix Medical Systems, Inc. 2
- Akron City Hospital 1
- Given Imaging , Ltd. 1
- Technomanagement, Inc. C/O C.G. 1
- Tonometrics Holdings SA C/O Mackeen Consultants 1
- Zinetics Medical Technology Corp. 1
- Oxford Medilog, Inc. 1
- Konigsberg Instruments, Inc. 1
- World Precision Instruments, Inc. 1
- Settler Medical Electronics, Inc. 1
- Synectics AB 1
- American Endoscopy, Inc. 1
- Del Mar Avionics 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102543 | Bravo PH Monitoring System and AccessoriesFFT · Traditional | Given Imaging , Ltd. | 12/01/2010SE |
| K013951 | Sandhill Scientific Pediatec PH ProbeFFT · Traditional | Sandhill Scientific, Inc. | 02/28/2002SE |
| K002028 | Bravo PH Monitoring SystemFFT · Traditional | Endonetics, Inc. | 09/29/2000SE |
| K961346 | PH Analysis ModuleFFT · Traditional | Synectics-Dantec | 01/29/1997SE |
| K950087 | Lot 440FFT · Traditional | Medical Instruments Corporation Mic AG | 02/06/1996SE |
| K955018 | Trip NGS & Sigmoid Catheter Phi Slide CalculatorFFT · Traditional | Instrumentarium Corp. | 01/30/1996SE |
| K945069 | Flexilog 2000FFT · Traditional | Oakfield Instruments, Ltd. | 06/13/1995SE |
| K920849 | Trip Cic CatheterFFT · Traditional | Tonometrics, Inc. | 03/17/1995SE |
| K934434 | Cyberrx Model 7200FFT · Traditional | Cybermed Control Systems, Inc. | 01/24/1995SE |
| K925405 | Zinetics Composite Sensor Probe W/Internal Ref.FFT · Traditional | Synectics-Dantec | 09/30/1994SE |
| K931963 | Sandhill Disposable Internal Reference PH ProbeFFT · Traditional | Sandhill Scientific, Inc. | 09/28/1994SE |
| K913817 | Monocrystant Ph-Reference Catheter, ModificationFFT · Traditional | Synectics-Dantec | 06/11/1992SE |
| K914624 | PH Meter, ModificationFFT · Traditional | Synectics-Dantec | 04/28/1992SE |
| K912772 | SuperloggerFFT · Traditional | Sandhill Scientific, Inc. | 02/07/1992SE |
| K913387 | Digitrapper Mark IIIFFT · Traditional | Synectics-Dantec | 12/27/1991SE |
| K911825 | Trip(Tm) Nasogastric Sump CatheterFFT · Traditional | Tonometrics, Inc. | 07/23/1991SE |
| K910694 | Zinetics Internal Reference ProbeFFT · Traditional | Zinetics Medical, Inc. | 05/17/1991SE |
| K903646 | GastrographFFT · Traditional | Medics Instrument Corp. | 11/05/1990SE |
| K902366 | Modified Proxima Monitor/Digitrapper Ed UnitFFT · Traditional | Synectics-Dantec | 06/08/1990SE |
| K896288 | Flexilog 1010 Ambulatory PH Monitoring SystemFFT · Traditional | Oakfield Instruments, Ltd. | 05/04/1990SE |
| K883960 | Giphy MonitorFFT · Traditional | Vascular Technology Incorporated | 10/04/1989SE |
| K891410 | Nasogastric PH Suction Catheter, ST-5001FFT · Traditional | Sensatronix Medical Systems, Inc. | 06/23/1989SE |
| K883234 | Tonomitor (TM) + SumpFFT · Traditional | Tonometrics, Inc. | 10/12/1988SE |
| K881706 | Proxima 1 PH MonitorFFT · Traditional | Technomanagement, Inc. C/O C.G. | 07/12/1988SE |
| K874710 | Diamond Medical, Inc. Model DM 600FFT · Traditional | Diamond Medical, Inc. | 02/08/1988SE |
| K874709 | Diamond Medical, Inc. Model DM 800FFT · Traditional | Diamond Medical, Inc. | 02/08/1988SE |
| K875369 | Model ISO-2001 Univ. Patient Isolation CircuitFFT · Traditional | Diamond Medical, Inc. | 02/05/1988SE |
| K871922 | Portable PH, MV, Temp Meter W/Auto. Temp Compensa.FFT · Traditional | Chemfet Corp. | 10/20/1987SE |
| K871921 | General Purpose Combination PH ElectrodeFFT · Traditional | Chemfet Corp. | 10/20/1987SE |
| K872929 | PH Monitoring SystemFFT · Traditional | Sensatronix Medical Systems, Inc. | 08/10/1987SE |
| K871282 | Synectics Liberty System Amplifier and SoftwareFFT · Traditional | Synectics-Dantec | 06/10/1987SE |
| K870606 | Tonomitor(Tm)FFT · Traditional | Tonometrics Holdings SA C/O Mackeen Consultants | 04/10/1987SE |
| K863298 | Diamond Medical, Inc., Model DM 700FFT · Traditional | Diamond Medical, Inc. | 03/17/1987SE |
| K862727 | Zinetics Gastrometer (TM)FFT · Traditional | Zinetics Medical Technology Corp. | 11/19/1986SE |
| K862929 | Synectics Motility SystemFFT · Traditional | Synectics-Dantec | 10/20/1986SE |
| K862536 | Model 1010 Ambulatory PH Monitoring SystemFFT · Traditional | Oxford Medilog, Inc. | 09/12/1986SE |
| K854514 | AMBI-24 Ph/Pressure MonitorFFT · Traditional | Biosearch Medical Products, Inc. | 02/24/1986SE |
| K853280 | Four Channel PH ProbeFFT · Traditional | Akron City Hospital | 12/02/1985SE |
| K853648 | Synectics Liberty Sys Compris Digitrapper MK II MoFFT · Traditional | Synectics-Dantec | 11/18/1985SE |
| K852289 | Model SA3 Esophageal PH ElectrodeFFT · Traditional | World Precision Instruments, Inc. | 07/25/1985SE |
| K850778 | Set -502T PH Esophageal Micro Size ElectrodeFFT · Traditional | Settler Medical Electronics, Inc. | 06/13/1985SE |
| K850361 | Synectics PH Sys Comprising Digitrapper Mark II, EFFT · Traditional | Synectics-Dantec | 05/01/1985SE |
| K850074 | Esophogeal PH CatheterFFT · Traditional | Biosearch Medical Products, Inc. | 02/14/1985SE |
| K842690 | Synectics PH & Pressure Esophageal MonitFFT · Traditional | Synectics AB | 11/08/1984SE |
| K841384 | Proxima 1 PH MonitorFFT · Traditional | American Endoscopy, Inc. | 07/19/1984SE |
| K834512 | Sandmill RMSFFT · Traditional | Sandhill Scientific, Inc. | 02/21/1984SE |
| K822815 | Model 700 Gastroreflux Monitor/AmalyzerFFT · Traditional | Del Mar Avionics | 10/22/1982SE |
| K820566 | Patient Isolator #S-10/D-10FFT · Traditional | Microelectrodes, Inc. | 03/23/1982SE |
| K811083 | Esophageal Motility ProbeFFT · Traditional | Konigsberg Instruments, Inc. | 08/13/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3090-2026 Class I | Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule…Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient… | Given Imaging Ltd. | 08/06/2026Open, Classified |
| Z-2047-2025 Class I | Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule…It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its… | Given Imaging Ltd. | 06/03/2025Open, Classified |
| Z-1335-2021 Class II | BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used…The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the… | Covidien Llc | 02/26/2021Open, Classified |
| Z-1334-2021 Class II | CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used…The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the… | Covidien Llc | 02/26/2021Open, Classified |
| Z-1620-2016 Class II | Given Imaging Bravo pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH…Potential of an allergic reaction in a patient with nickel sensitivity. | Covidien LLC | 04/15/2016Terminated |
| Z-1619-2016 Class II | Given Imaging Bravo pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH…Potential of an allergic reaction in a patient with nickel sensitivity. | Covidien LLC | 04/15/2016Terminated |
| Z-0517-2008 | Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers…Unable to detach from source: The capsule may not detach from the delivery system following attachment to… | Medtronic Neuromodulation | 12/03/2007Terminated |