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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

K233220 is an FDA 510(k) premarket notification submitted by Senorx, Inc. for the device "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)". The FDA issued a decision of Substantially Equivalent on October 27, 2023. 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
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.

  • K210654 — EnCor Breast Biopsy Probe with Rinse Tube (March 31, 2021)
  • 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)

Other clearances for product code KNW

  • K261196 — Promisemed VeriEcto Automatic Biopsy Needles (May 12, 2026)
  • K260365 — Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Ma (March 4, 2026)
  • K252795 — ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy De (February 23, 2026)
  • K252681 — EnCor EnCompass™ Breast Biopsy and Tissue Removal System (December 12, 2025)
  • K252183 — Resitu Slider 09 (RESL09) (September 24, 2025)
  • K243407 — Forcyte Autograft Harvest Kit (July 29, 2025)
  • K244018 — Disposable Biopsy Needle (July 22, 2025)
  • K243296 — Disposable Biopsy Needle (July 11, 2025)
  • K250032 — Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (July 10, 2025)
  • K243886 — ExpressCore Biopsy Device (April 29, 2025)

FDA data resources