510(k) K101561 ยท LFL Instrument, Ultrasonic Surgical
TX1 TISSUE REMOVAL SYSTEM
| Applicant | American Optisurgical, Inc., Lake Forest CA, US |
| Decision | Substantially Equivalent, Aug 27, 2010 |
| Received | Jun 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101561
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2013 | American Optisurgical Inc TX1 Tissue Removal System Console. Model: TX1
TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation Terminated |
LFL | None listed |
| Jun 6, 2013 | American Optisurgical Inc American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. Terminated |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.