510(k) K180233
K180233 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Eviva Stereotactic Guided Breast Biopsy System". The FDA issued a decision of Substantially Equivalent on Apr 10, 2018. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Hologic, Inc. has 119 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 10, 2018
- Date Received
- Jan 29, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type
- 510(k)