510(k) K161128 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
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, Baar, CH |
| Decision | Substantially Equivalent, Dec 1, 2016 |
| Received | Apr 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161128
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2018 | Medela Inc Invia Motion Negative Pressure Wound Therapy System. Labeled as:
a. Endure Negative Pressure Wound Therapy (Model 087.4010);
b. 15 Days Negative Pressure Wound Therapy (Model 087.4012);
c. 60 Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.