| Device Type ID | 1808 |
| Device Name | Retractor, Self-retaining |
| Regulation Description | Manual Gastroenterology-urology Surgical Instrument 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 | 876.4730 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FFO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1808 |
| Device | Retractor, Self-retaining |
| Product Code | FFO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Gastroenterology-urology Surgical Instrument And Accessories. |
| CFR Regulation Number | 876.4730 [🔎] |
| Device Problems | |
|---|---|
Device Dislodged Or Dislocated | 21 |
Unintended Movement | 18 |
Break | 10 |
Device Slipped | 10 |
Mechanical Problem | 4 |
Component Or Accessory Incompatibility | 3 |
Device Operates Differently Than Expected | 2 |
Device Reprocessing Problem | 1 |
Contamination During Use | 1 |
Material Integrity Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Shipping Damage Or Problem | 1 |
Use Of Device Problem | 1 |
Device Handling Problem | 1 |
Device Maintenance Issue | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Device Contamination With Chemical Or Other Material | 1 |
| Total Device Problems | 78 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abeon Medical Corporation | II | Jan-21-2016 |