SIGNAL GEAR URETHRAL CATHETER ELECTRODE— 510(k) K113771
Substantially EquivalentNeurovision Medical Products, Inc.
FDA 510(k) clearance K113771 for SIGNAL GEAR URETHRAL CATHETER ELECTRODE, Substantially Equivalent on 2012-12-13. Applicant: Neurovision Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Neurovision Medical Products, Inc.
- Product code
- Code FAP
- Device class
- Class 2
- Regulation
- 21 CFR 876.1620
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ventura, CA, US
Recent devices under product code FAP
view allMore clearances from Neurovision Medical Products, Inc.
view allRecalls naming K113771
K-number listed on FDA's recall record- Z-1968-2021 — 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 UE006
- Z-1970-2021 — 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 UE002
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113771.
Data sourced from openFDA. This site is unofficial and independent of the FDA.