Clearance Summary
Sentinel BreastScan II System received FDA 510(k) clearance under submission number K162767, sponsored by First Sense Medical, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2017-01-09.
- Submission: K162767
- Applicant / Sponsor: First Sense Medical, LLC
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 2017-01-09
Classification & Regulation
This clearance is catalogued under FDA product code LHQ and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class I device.