510(k) K140679 ยท GEX Powered Laser Surgical Instrument
SUREFLEX LITHOTRIPSY LASER FIBERS
| Applicant | American Medical Systems, San Jose CA, US |
| Decision | Substantially Equivalent, Jun 20, 2014 |
| Received | Mar 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140679
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley 200M Lithotripsy Fiber- Reusable;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley 365M Lithotripsy Fiber- Reusable;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.