510(k) K163541
K163541 is an FDA 510(k) premarket notification submitted by Endomagnetics Ltd., for the device "Magseed Magnetic Marker System". The FDA issued a decision of Substantially Equivalent on January 13, 2017. The device falls under product code PBY (Temporary Tissue Marker), a Class II device regulated under 21 CFR 878.4300. Endomagnetics Ltd., has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2017
- Date Received
- December 16, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporary Tissue Marker
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type
To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.