510(k) K914516 ยท FFK Lithotriptor, Electro-Hydraulic
9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
| Applicant | Northgate Technologies, Inc., Arlington Heights IL, US |
| Decision | Substantially Equivalent, Jan 7, 1992 |
| Received | Oct 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914516
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2020 | Northgate Technologies, Inc. ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary Terminated |
FFK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.