Definition: For Use As An Adjunctive Device During Open Surgical Procedures In Order To Prevent Fluid Accumulation Within The Operative Site After Closure Of The Surgical Wound. The Device Is Indicated For Use In Thoracic Surgical Procedures.
| Device Type ID | 5825 |
| Device Name | Wound Drain Catheter System |
| Physical State | The System Comprise Of A Silicone Drainge Tube, Guide Tube With Integrated Magnetic Shuttle Assembly. |
| Technical Method | The System Employs A Magnetic Clearance Mechanism Integrated Into The Drainage Tubing To Allow The User To Clear Materials Which May Accumulate Inside The Drainage Tube. |
| Target Area | For Use In Chest Areas Following Thoracic Surgical Procedures. |
| Regulation Description | Powered Suction Pump. |
| 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) |
| CFR Regulation Number | 878.4780 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OTK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5825 |
| Device | Wound Drain Catheter System |
| Product Code | OTK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Suction Pump. |
| CFR Regulation Number | 878.4780 [🔎] |
| Device Problems | |
|---|---|
Use Of Device Problem | 4 |
Detachment Of Device Component | 2 |
Mechanical Jam | 1 |
Detachment Of Device Or Device Component | 1 |
Torn Material | 1 |
Material Puncture / Hole | 1 |
| Total Device Problems | 10 |