510(k) K012445 ยท FFK Lithotriptor, Electro-Hydraulic
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
| Applicant | Electro Medical Systems SA, North Attleboro MA, US |
| Decision | Substantially Equivalent, Aug 24, 2001 |
| Received | Aug 1, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012445
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2009 | Boston Scientific Corp Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Terminated |
FFK | None listed |
| Mar 30, 2007 | E.M.S. - Electro Medical Systems SA Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System . Terminated |
FFK | None listed |
| Oct 31, 2003 | Electro Medical Systems (EMS SA) LithoClast Foot Pedal, reference EK-166
Catalog Number: 840-703
Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700.. Manufactured by EMS Electro Medical Systems S, Nyo Terminated |
FFK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.