Clearance Summary
SPECULUM, VAGINAL, METAL FIBEROPTIC received FDA 510(k) clearance under submission number K864865, sponsored by Luxtec 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 1987-01-09.
- Submission: K864865
- Applicant / Sponsor: Luxtec Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4520
- Decision date: 1987-01-09
Classification & Regulation
This clearance is catalogued under FDA product code HDG and 21 CFR 884.4520, within the Obstetrics/Gynecology review panel as a Class I device.