Clearance Summary
VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 received FDA 510(k) clearance under submission number K092107, sponsored by Nidacon International AB. 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 2010-06-15.
- Submission: K092107
- Applicant / Sponsor: Nidacon International AB
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2010-06-15
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.