Definition: To Examine And Perform Procedures Within The Anus And Rectum.
| Device Type ID | 1792 |
| Device Name | Anoscope And Accessories |
| Physical State | Endoscope, Accessories Associated With Anoscope Such As Mini-scope |
| Technical Method | Instrument Inserted Through Anus Into Rectum |
| Target Area | Anus And Rectum |
| 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 | FER |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1792 |
| Device | Anoscope And Accessories |
| Product Code | FER |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APPLIED MEDICAL RESOURCES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
APPLIED MEDICAL RESOURCES CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Detachment Of Device Component | 13 |
Use Of Device Problem | 3 |
Material Fragmentation | 2 |
Break | 2 |
Output Problem | 1 |
Torn Material | 1 |
Difficult To Remove | 1 |
Gas Leak | 1 |
| Total Device Problems | 24 |