510(k) K130368 ยท FFK Lithotriptor, Electro-Hydraulic
AUTOLITH TOUCH; URO TOUCH
| Applicant | Northgate Technologies, Inc., Elgin IL, US |
| Decision | Substantially Equivalent, Nov 15, 2013 |
| Received | Feb 14, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130368
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2022 | Northgate Technologies, Inc. AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe Terminated |
FFK | None listed |
| Oct 25, 2021 | Northgate Technologies, Inc. Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800.
The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragme Open, Classified |
FFK | None listed |
| Mar 24, 2020 | Northgate Technologies, Inc. Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi. Terminated |
FFK | None listed |
| Mar 24, 2020 | Northgate Technologies, Inc. AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi. Terminated |
FFK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.