510(k) K123640 ยท LFL Instrument, Ultrasonic Surgical
TX1 TISSUE REMOVAL SYSTEM
| Applicant | Tenex Health, Lake Forest, CA, US |
| Decision | Substantially Equivalent, Mar 20, 2013 |
| Received | Nov 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2014 | Tenex Health Inc TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft Terminated |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.