Definition: An Endoscope Bulb Pressurizes The Interior Of An Endoscope. The User Identifies The Presence Of Leaks In The Endoscope By Immersing In Water And Visually Observing For Bubbles.
| Device Type ID | 1762 |
| Device Name | Bulb, Inflation, For Endoscope |
| Technical Method | The User May Select And Maintain The Pressure, Or The Device May Control And Maintain The Selected Pressure. |
| 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) Exempt |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FCY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1762 |
| Device | Bulb, Inflation, For Endoscope |
| Product Code | FCY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |