Device Type ID | 1696 |
Device Name | Adaptor, Ureteral Catheter |
Regulation Description | Urological Catheter 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 | 876.5130 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | EYI |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |