Clearance Summary
VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 received FDA 510(k) clearance under submission number K023019, sponsored by Vomed Volzer Medizintechnik GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2002-12-10.
- Submission: K023019
- Applicant / Sponsor: Vomed Volzer Medizintechnik GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2002-12-10
Classification & Regulation
This clearance is catalogued under FDA product code FGI and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.