510(k) K050108 ยท GEX Powered Laser Surgical Instrument
SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS
| Applicant | Innovaquartz, Phoenix AZ, US |
| Decision | Substantially Equivalent, Mar 14, 2005 |
| Received | Jan 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050108
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Sureflex 150 Lithotripsy Fiber, 5x, Blue;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical pr Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Sureflex 200 Lithotripsy Fiber, 5x, Blue;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical pr Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Sureflex 273 Lithotripsy Fiber, 5x, Blue;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical pr Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Sureflex 365 Lithotripsy Fiber, 5x, Blue;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical pr Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Sureflex 550 Lithotripsy Fiber, 5x, Blue;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical pr Terminated |
GEX | None listed |
| Jul 21, 2015 | American Medical Systems Innovation Center - Silicon Valley Sureflex 910 Lithotripsy Fiber, 5x, Blue;
Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical pr Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.