| Device Type ID | 1813 |
| Device Name | Electrode, Ph, Stomach |
| Regulation Description | Stomach PH Electrode. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.1400 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FFT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1813 |
| Device | Electrode, Ph, Stomach |
| Product Code | FFT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Stomach PH Electrode. |
| CFR Regulation Number | 876.1400 [🔎] |
| Device Problems | |
|---|---|
Failure To Adhere Or Bond | 1849 |
Positioning Failure | 400 |
Loss Of Or Failure To Bond | 164 |
Communication Or Transmission Problem | 148 |
Detachment Of Device Component | 103 |
Device Operates Differently Than Expected | 72 |
Detachment Of Device Or Device Component | 64 |
Failure To Transmit Record | 53 |
Adverse Event Without Identified Device Or Use Problem | 53 |
Entrapment Of Device | 46 |
Difficult Or Delayed Positioning | 39 |
High PH | 22 |
Unintended Application Program Shut Down | 21 |
Missing Test Results | 20 |
Device Displays Incorrect Message | 19 |
Signal Artifact | 19 |
Misconnection | 9 |
Data Problem | 9 |
Insufficient Information | 9 |
Poor Quality Image | 8 |
Loss Of Data | 8 |
Failure To Calibrate | 8 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 6 |
Separation Failure | 5 |
Invalid Sensing | 5 |
High Readings | 5 |
Connection Problem | 4 |
Device Operational Issue | 4 |
Failure To Power Up | 4 |
Output Problem | 3 |
Material Distortion | 3 |
Image Resolution Poor | 3 |
Power Problem | 3 |
No Display / Image | 3 |
Activation, Positioning Or Separation Problem | 2 |
Chemical Problem | 2 |
Intermittent Continuity | 2 |
Material Integrity Problem | 2 |
Difficult To Remove | 2 |
Failure To Sense | 2 |
Failure To Disconnect | 2 |
Malposition Of Device | 2 |
Difficult To Insert | 2 |
Break | 2 |
Mechanical Problem | 2 |
Calibration Problem | 2 |
Loss Of Power | 2 |
Component Incompatible | 1 |
False Device Output | 1 |
Material Deformation | 1 |
Noise, Audible | 1 |
No Device Output | 1 |
Premature Activation | 1 |
Incorrect Or Inadequate Test Results | 1 |
Loose Or Intermittent Connection | 1 |
Device Damaged Prior To Use | 1 |
Grounding Malfunction | 1 |
Positioning Problem | 1 |
Patient-Device Incompatibility | 1 |
Bent | 1 |
Human-Device Interface Problem | 1 |
Compatibility Problem | 1 |
| Total Device Problems | 3232 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Covidien LLC | II | May-06-2016 |