| Device Type ID | 1980 |
| Device Name | Evacuator, Gastro-urology |
| Regulation Description | Gastroenterology-urology Evacuator. |
| 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 | 876.4370 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KQT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1980 |
| Device | Evacuator, Gastro-urology |
| Product Code | KQT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastroenterology-urology Evacuator. |
| CFR Regulation Number | 876.4370 [🔎] |
| Device Problems | |
|---|---|
Device Contaminated During Manufacture Or Shipping | 1 |
Decrease In Suction | 1 |
Break | 1 |
Inadequate Instructions For Healthcare Professional | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Civco Medical Instruments Inc | II | Aug-28-2014 |