510(k) K113771 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
SIGNAL GEAR URETHRAL CATHETER ELECTRODE
| Applicant | Neurovision Medical Products, Inc., Ventura CA, US |
| Decision | Substantially Equivalent, Dec 13, 2012 |
| Received | Dec 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113771
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2021 | Spes Medica SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number Terminated |
FAP | None listed |
| Apr 8, 2021 | Spes Medica SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number Terminated |
FAP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.