CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR— 510(k) K914101
Substantially EquivalentCircon Video
FDA 510(k) clearance K914101 for CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR, Substantially Equivalent on 1991-11-22. Applicant: Circon Video. Device class: 2.
Clearance details
- Applicant
- Circon Video
- Product code
- Code HIF
- Device class
- Class 2
- Regulation
- 21 CFR 884.1730
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stanford, CT, US
Recent devices under product code HIF
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 HIF
product code HIF- Death
- 19
- Injury
- 578
- Malfunction
- 5,639
- Total
- 6,236
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.