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510(k) K072541

SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM by Senorx, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2007
Date Received
September 10, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
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)

Other clearances for product code ITX

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  • K250762 — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20 (July 11, 2025)
  • K250524 — Mendaera Guidance System (July 2, 2025)
  • K250469 — Accuro® 3S Needle Guide Kit (June 13, 2025)
  • K241662 — Ultrasound Transducer Cover (August 30, 2024)
  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K241615 — Transducer Probe Cover (July 3, 2024)
  • K233109 — TP Pivot Pro™ Needle Guide (December 22, 2023)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231783 — VitroPRO (November 14, 2023)