| Device Type ID | 5713 |
| Device Name | Ring (wound Protector), Drape Retention, Internal |
| Regulation Description | Surgical Drape And Drape Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4370 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KGW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 5713 |
| Device | Ring (wound Protector), Drape Retention, Internal |
| Product Code | KGW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Drape And Drape Accessories. |
| CFR Regulation Number | 878.4370 [🔎] |
| Device Problems | |
|---|---|
Material Perforation | 55 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Detachment Of Device Component | 3 |
Material Separation | 2 |
Break | 2 |
Use Of Device Problem | 2 |
Device Dislodged Or Dislocated | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Device Operates Differently Than Expected | 2 |
Material Split, Cut Or Torn | 1 |
Particulates | 1 |
Retraction Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Packaging Problem | 1 |
Torn Material | 1 |
Material Fragmentation | 1 |
| Total Device Problems | 85 |