Device Type ID | 1781 |
Device Name | Obturator, For Endoscope |
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 | FEC |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
|
Device Type ID | 1781 |
Device | Obturator, For Endoscope |
Product Code | FEC |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Endoscope And Accessories. |
CFR Regulation Number | 876.1500 [🔎] |
Device Problems | |
---|---|
Detachment Of Device Component | 1 |
Flaked | 1 |
Break | 1 |
Tip | 1 |
Total Device Problems | 4 |