FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735— 510(k) K012929
Substantially EquivalentCircon Video
FDA 510(k) clearance K012929 for FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735, Substantially Equivalent on 2001-11-19. Applicant: Circon Video. Device class: 2.
Clearance details
- Applicant
- Circon Video
- Product code
- Code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Barbara, CA, US
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More clearances from Circon Video
view all- K012758 — URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,
- K011876 — DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
- K011849 — MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS
- K012951 — APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
- K012925 — DUR-8, MODELS DUR-8
Adverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.