OPTION-VF URINARY CATHETER, FV14218— 510(k) K023090
Substantially EquivalentOpticon Medical, Inc.
FDA 510(k) clearance K023090 for OPTION-VF URINARY CATHETER, FV14218, Substantially Equivalent on 2003-03-19. Applicant: Opticon Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Opticon Medical, Inc.
- Product code
- Code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dublin, OH, US
Recent devices under product code EZL
view allMore clearances from Opticon Medical, Inc.
view all- K033830 — OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000
- K970716 — OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
- K930194 — HEMOSTASIS VALVE AND TUBING SET
- K904999 — WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE
- K895955 — LOPER CELIAC PLEXUS BLOCK CATHETER KIT
Adverse events under product code EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
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 →
Recalls naming K023090
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023090.
Data sourced from openFDA. This site is unofficial and independent of the FDA.