510(k) K210654

EnCor Breast Biopsy Probe with Rinse Tube by Senorx, Inc. — Product Code KNW

K210654 is an FDA 510(k) premarket notification submitted by Senorx, Inc. for the device "EnCor Breast Biopsy Probe with Rinse Tube". The FDA issued a decision of Substantially Equivalent on March 31, 2021. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Senorx, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2021
Date Received
March 4, 2021
Clearance Type
Special
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