CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG— 510(k) K914883
Substantially EquivalentCircon Video
FDA 510(k) clearance K914883 for CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG, Substantially Equivalent on 1993-01-15. Applicant: Circon Video. Device class: 2.
Clearance details
- Applicant
- Circon Video
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stanford, CT, US
Recent devices under product code GEI
view allMore 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
- K012929 — FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
- K012951 — APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.