Definition: To Allow Endoscopes To Soak In Reprocessing Solutions.
| Device Type ID | 2094 |
| Device Name | Basin For Endoscope Reprocessing |
| Physical State | The Device Is Comprised Of A Basin That May Be Molded To More Closely Meet The Contours Of A Coiled Endoscope. The Device May Include A Heater And Temperature Monitor. |
| Technical Method | The Basin May Be Contoured To Minimize The Volume Of Reprocessing Solution Used. The Basin May Also Have A Temperature Control. The Basin Does Not Include Flushing Technology. |
| Target Area | Flexible Gastrointestinal 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 | PHT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2094 |
| Device | Basin For Endoscope Reprocessing |
| Product Code | PHT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |