HYDROPHILIC COATED GUIDEWIRE— 510(k) K926344
Substantially EquivalentSurgitek
FDA 510(k) clearance K926344 for HYDROPHILIC COATED GUIDEWIRE, Substantially Equivalent on 1993-03-05. Applicant: Surgitek. Device class: 2.
Clearance details
- Applicant
- Surgitek
- Product code
- Code KNY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Racine, WI, US
Recent devices under product code KNY
view allMore clearances from Surgitek
view allData sourced from openFDA. This site is unofficial and independent of the FDA.