FFT · Electrode, Ph, Stomach
Gastroenterology, Urology · 21 CFR 876.1400 · Class 1
Overview
| Product Code | FFT |
|---|---|
| Device Name | Electrode, Ph, Stomach |
| Regulation | 21 CFR 876.1400 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.
Classification Rationale
Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Recent Cleared Devices (20 of 49)
Showing 20 most recent of 49 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | Given Imaging , Ltd. | Dec 1, 2010 | SESE |
| K013951 | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | Sandhill Scientific, Inc. | Feb 28, 2002 | SESE |
| K002028 | BRAVO PH MONITORING SYSTEM | Endonetics, Inc. | Sep 29, 2000 | SESE |
| K961346 | PH ANALYSIS MODULE | Synectics-Dantec | Jan 29, 1997 | SESE |
| K950087 | LOT 440 | Medical Instruments Corporation Mic AG | Feb 6, 1996 | SESE |
| K955018 | TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR | Instrumentarium Corp. | Jan 30, 1996 | SESE |
| K945069 | FLEXILOG 2000 | Oakfield Instruments, Ltd. | Jun 13, 1995 | SESE |
| K920849 | TRIP CIC CATHETER | Tonometrics, Inc. | Mar 17, 1995 | SESE |
| K934434 | CYBERRX MODEL 7200 | Cybermed Control Systems, Inc. | Jan 24, 1995 | SESE |
| K925405 | ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. | Synectics-Dantec | Sep 30, 1994 | SESE |
| K931963 | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE | Sandhill Scientific, Inc. | Sep 28, 1994 | SESE |
| K913817 | MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION | Synectics-Dantec | Jun 11, 1992 | SESE |
| K914624 | PH METER, MODIFICATION | Synectics-Dantec | Apr 28, 1992 | SESE |
| K912772 | SUPERLOGGER | Sandhill Scientific, Inc. | Feb 7, 1992 | SESE |
| K913387 | DIGITRAPPER MARK III | Synectics-Dantec | Dec 27, 1991 | SESE |
| K911825 | TRIP(TM) NASOGASTRIC SUMP CATHETER | Tonometrics, Inc. | Jul 23, 1991 | SESE |
| K910694 | ZINETICS INTERNAL REFERENCE PROBE | Zinetics Medical, Inc. | May 17, 1991 | SESE |
| K903646 | GASTROGRAPH | Medics Instrument Corp. | Nov 5, 1990 | SESE |
| K902366 | MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT | Synectics-Dantec | Jun 8, 1990 | SESE |
| K896288 | FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM | Oakfield Instruments, Ltd. | May 4, 1990 | SESE |
Top Applicants
- Synectics-Dantec — 10 clearances
- Diamond Medical, Inc. — 4 clearances
- Sandhill Scientific, Inc. — 4 clearances
- Tonometrics, Inc. — 3 clearances
- Biosearch Medical Products, Inc. — 2 clearances
