Clearance Summary
USG 2000SA received FDA 510(k) clearance under submission number K023227, sponsored by Ultraguide , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2002-10-22.
- Submission: K023227
- Applicant / Sponsor: Ultraguide , Ltd.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2225
- Decision date: 2002-10-22
Classification & Regulation
This clearance is catalogued under FDA product code HHJ and 21 CFR 884.2225, within the Obstetrics/Gynecology review panel as a Class II device.