Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply
FDA 510(k) clearance K161128 · decided 2016-12-01
Clearance details
- K-number
- K161128
- Device name
- Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply
- Applicant
- Medela AG
- Decision
- Substantially Equivalent
- Date received
- 2016-04-21
- Decision date
- 2016-12-01
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- OMP
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Baar, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressu recall (Z-2528-2018) | Medela Inc | 2018-07-23 |