Clearance Summary
ZEISS OPMI L STEREO-LAPAROSCOPE received FDA 510(k) clearance under submission number K931478, sponsored by Carl Zeiss, Inc.. 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 1994-09-28.
- Submission: K931478
- Applicant / Sponsor: Carl Zeiss, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1994-09-28
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.