510(k) K023019
K023019 is an FDA 510(k) premarket notification submitted by Vomed Volzer Medizintechnik GmbH & Co. for the device "VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000". The FDA issued a decision of Substantially Equivalent on December 10, 2002. The device falls under product code FGI (Catheter, Urethrographic, Male), a Class II device regulated under 21 CFR 876.5130. Vomed Volzer Medizintechnik GmbH & Co. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2002
- Date Received
- September 11, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urethrographic, Male
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type