510(k) K011065 ยท FFK Lithotriptor, Electro-Hydraulic
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
| Applicant | Richard Wolf Medical Instruments Corp., Vernon Hills IL, US |
| Decision | Substantially Equivalent, May 9, 2001 |
| Received | Apr 9, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Richard Wolf Medical Instrument Corp Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Richard Wolf Model 2271 Ultrasound Generator Unit 2271; Richard Wolf Medical Instrum Terminated |
FFK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.