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 | ||
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Manufacturer | Decision | |
PRESCIENT SURGICAL | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 |