Home / 510(k) Clearances / K233220

510(k) K233220

EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT) by Senorx, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2023
Date Received
September 28, 2023
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

Other clearances by Senorx, Inc.

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  • K161805 — EnCor MRI Introducer Set, EnCor Probe Introducer (July 19, 2016)
  • K131654 — STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER (June 27, 2013)
  • K093512 — ENCOR BREAST BIOPSY SYSTEM (November 20, 2009)
  • K092323 — CONTURA CAVITY MAINTENANCE CATHETER (August 19, 2009)
  • K082264 — CONTURA LUMEN MARKER (September 12, 2008)
  • K081085 — STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS (August 1, 2008)
  • K081170 — PROSTATE TISSUE MARKER (May 28, 2008)
  • K081079 — CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY (May 2, 2008)
  • K080791 — CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 (April 30, 2008)

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