510(k) K052135 ยท FFK Lithotriptor, Electro-Hydraulic
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
| Applicant | Cybersonics, Inc., Erie PA, US |
| Decision | Substantially Equivalent, Dec 20, 2005 |
| Received | Aug 5, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K052135
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2007 | Gyrus ACMI Corporation Gyrus CyberWand Ultrasonic Lithotripter System includes:
CW-USLS CyberWand USL System
CW-USLT CyberWand USL Transducer
CW-USLRBP CyberWand USL Renal/Bladder Probe Set
CW-USLTT CyberWand USL Transduce Terminated |
FFK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.