Panels › Gastroenterology, Urology › Product code FFT · Class 1
Electrode, Ph, Stomach
Regulation 876.1400
0510(k)s in 12 months (49 all time)
1recalls in 12 months (11 all time)
8recalls that name a 510(k)
Top companies in FFT
| Company | 510(k)s | Recalls |
|---|---|---|
| Synectics-Dantec | 10 | 0 |
| Sandhill Scientific, Inc. | 4 | 2 |
| Covidien LLC | 0 | 4 |
| Diamond Medical, Inc. | 4 | 0 |
| Given Imaging , Ltd. | 1 | 2 |
| Tonometrics, Inc. | 3 | 0 |
| Biosearch Medical Products, Inc. | 2 | 0 |
| Chemfet Corp. | 2 | 0 |
| Medtronic Gastroenterology / Urology | 0 | 2 |
| Oakfield Instruments, Ltd. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Given Imaging Ltd. Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635,
Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus. Open, Classified |
FFT | None listed |
| Jul 10, 2025 | Given Imaging Ltd. Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack) Open, Classified |
FFT | K102543 |
| Feb 26, 2021 | Covidien Llc BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. Open, Classified |
FFT | K102543 |
| Feb 26, 2021 | Covidien Llc CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. Open, Classified |
FFT | K102543 |
| May 6, 2016 | Covidien LLC 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 gastro Terminated |
FFT | K002028 |
| May 6, 2016 | Covidien LLC 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 gastroe Terminated |
FFT | K002028 |
| May 7, 2008 | Medtronic Neuromodulation Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001. Medtronic, Inc., Minneapolis, MN 55432 Terminated |
FFT | K002028 |
| May 3, 2006 | Medtronic Gastroenterology / Urology Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. Distributed by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapoli Terminated |
FFT | None listed |
| Jan 13, 2006 | Medtronic Gastroenterology / Urology Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012P3141. Distributed by / Medtronic Inc. Terminated |
FFT | None listed |
| Nov 11, 2003 | Sandhill Scientific, Inc ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system Terminated |
FFT | K931963 |
| Jan 23, 2003 | Sandhill Scientific, Inc ''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually. Terminated |
FFT | K931963 |
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