OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE— 510(k) K970716
Substantially EquivalentOpticon Medical, Inc.
FDA 510(k) clearance K970716 for OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE, Substantially Equivalent on 1997-05-16. 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
- Minneapolis, MN, 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
- K023090 — OPTION-VF URINARY CATHETER, FV14218
- 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.