Eviva Stereotactic Guided Breast Biopsy System
FDA 510(k) clearance K180233 · decided 2018-04-10
Clearance details
- K-number
- K180233
- Device name
- Eviva Stereotactic Guided Breast Biopsy System
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-01-29
- Decision date
- 2018-04-10
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Malborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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