510(k) K111285 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING
| Applicant | Salient Surgical Technologies, Inc., Portsmouth NH, US |
| Decision | Substantially Equivalent, Sep 9, 2011 |
| Received | May 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111285
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2014 | Medtronic Advanced Energy, LLC Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories)
The Aquamantys3 System combines radio frequency Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.