Clearance Summary
SPECULITE received FDA 510(k) clearance under submission number K963391, sponsored by Trylon 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 1997-12-12.
- Submission: K963391
- Applicant / Sponsor: Trylon Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1997-12-12
Classification & Regulation
This clearance is catalogued under FDA product code MPU and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.