Definition: A Prescription Device Intended To Be Used By A Surgeon To Retract The Surgical Incision, To Provide Access To The Surgical Wound, To Protect And Irrigate The Surgical Wound, And To Serve As A Conduit For Removal Of Fluid From The Surgical Wound.
| Device Type ID | 5874 |
| Device Name | Wound Retraction And Protection System |
| Physical State | The Device Is Comprised Of A Flexible, Double-walled Sheath With An Impermeable Inner Layer. The Retraction Component Is Formed By Attaching The Sheath To A Fixed-diameter Ring At The Bottom Of The Device. The Sheath Also Includes An Integrated Fluid |
| Technical Method | The Device Is Sterile, Single-use Surgical Wound Retraction That Integrates Surgical Retraction, Wound Barrier Protection, And Fluid Delivery And Removal. Fluid Is Delivered Via Gravitational Feed From An External Sterile Irrigation Solution Bag Into |
| Target Area | Abdomen |
| Regulation Description | Irrigating Wound Retractor Device. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4371 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PQI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5874 |
| Device | Wound Retraction And Protection System |
| Product Code | PQI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Irrigating Wound Retractor Device. |
| CFR Regulation Number | 878.4371 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PRESCIENT SURGICAL | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |