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.
| Device Type ID | 2086 |
| Device Name | Endoscopic Leak Tester |
| Physical State | Leak Detection Apparatus |
| Technical Method | The Device Automatically Detects Leaks. |
| Target Area | Flexible Endoscopes. |
| Regulation Description | Endoscope And Accessories. |
| 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) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PCV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2086 |
| Device | Endoscopic Leak Tester |
| Product Code | PCV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |