510(k) K171890
K171890 is an FDA 510(k) premarket notification submitted by Medical Park Co., Ltd. for the device "BEXCORE Breast Biopsy System, Biopsy Needle". The FDA issued a decision of Substantially Equivalent on Aug 20, 2018. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 20, 2018
- Date Received
- Jun 26, 2017
- 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)