Clearance Summary
VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES received FDA 510(k) clearance under submission number K022318, sponsored by Vomed Volzer Medizintechnik GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2002-09-19.
- Submission: K022318
- Applicant / Sponsor: Vomed Volzer Medizintechnik GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 2002-09-19
Classification & Regulation
This clearance is catalogued under FDA product code HIF and 21 CFR 884.1730, within the Obstetrics/Gynecology review panel as a Class II device.