Device Type ID | 1937 |
Device Name | Endoscope, Flexible |
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 | GCQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 1937 |
Device | Endoscope, Flexible |
Product Code | GCQ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Endoscope And Accessories. |
CFR Regulation Number | 876.1500 [🔎] |
Device Problems | |
---|---|
Detachment Of Device Or Device Component | 1 |
Contamination / Decontamination Problem | 1 |
Total Device Problems | 2 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Integrated Medical Systems Inc | II | Feb-25-2016 |