Clearance Summary
SPECULITE DISPOSABLE VAGINAL LIGHT received FDA 510(k) clearance under submission number K853257, sponsored by Trylon Associates, Ltd.. 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 1985-12-27.
- Submission: K853257
- Applicant / Sponsor: Trylon Associates, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1985-12-27
Classification & Regulation
This clearance is catalogued under FDA product code HIC and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.