Clearance Summary
LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT received FDA 510(k) clearance under submission number K943989, sponsored by Gabris Surgical Corp.. 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 1994-09-12.
- Submission: K943989
- Applicant / Sponsor: Gabris Surgical Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2700
- Decision date: 1994-09-12
Classification & Regulation
This clearance is catalogued under FDA product code HFO and 21 CFR 884.2700, within the Obstetrics/Gynecology review panel as a Class II device.