PCV
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Endoscopic Leak Tester
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- An endoscopic leak tester automatically detects leaks from endoscopes, without requiring visual observation for bubbles when the device is immersed in water, by assessing differences in air pressure inside the pressurized endoscope.
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| Record | Firm | Date |
|---|---|---|
| PENTAX Medical Auto Leakage Tester SHA-P6 (K212201) | Pentax of America, Inc. | 2021-10-01 |
| AUTOMATED ENDOSCOPE LEAK TESTER (K123704) | Olympus Medical Systems Corp. | 2013-02-04 |
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