Clearance Summary
Magseed Magnetic Marker System received FDA 510(k) clearance under submission number K163541, sponsored by Endomagnetics Ltd.,. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2017-01-13.
- Submission: K163541
- Applicant / Sponsor: Endomagnetics Ltd.,
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2017-01-13
Classification & Regulation
This clearance is catalogued under FDA product code PBY and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.