Device Type ID | 1786 |
Device Name | Instrument, Special Lens, 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) Exempt |
CFR Regulation Number | 876.1500 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | FEI |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1786 |
Device | Instrument, Special Lens, For Endoscope |
Product Code | FEI |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Endoscope And Accessories. |
CFR Regulation Number | 876.1500 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Medtronic | II | Dec-22-2016 |