510(k) K980492 ยท FFK Lithotriptor, Electro-Hydraulic
AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
| Applicant | Circon Acmi, Stamford CT, US |
| Decision | Substantially Equivalent, Nov 17, 1998 |
| Received | Feb 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980492
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | ACMI CORPORATION ACMI REF E-1F Electrohydraulic Lithotripsy Probe,
1.9 FR x 120CM Terminated |
FFK | None listed |
| Jul 20, 2004 | ACMI CORPORATION ACMI REF E-3F Electrohydraulic Lithotripsy Probe,
3 FR x 120CM Terminated |
FFK | None listed |
| Jul 20, 2004 | ACMI CORPORATION ACMI REF E-5F Electrohydraulic Lithotripsy Probe,
5FR x 60CM Terminated |
FFK | None listed |
| Jul 20, 2004 | ACMI CORPORATION ACMI REF E-9F Electrohydraulic Lithotripsy Probe,
9 FR x 60CM Terminated |
FFK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.