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510(k) K101373

EMBRACE by Izi Medical Products, Inc. — Product Code IZH

K101373 is an FDA 510(k) premarket notification submitted by Izi Medical Products, Inc. for the device "EMBRACE". The FDA issued a decision of Substantially Equivalent on September 15, 2010. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Izi Medical Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2010
Date Received
May 17, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

Other clearances by Izi Medical Products, Inc.

  • K191012 — Navigated Pedicle Access Kit (August 7, 2019)
  • K162265 — CushionCast Moldable Cushions (November 15, 2016)
  • K143241 — MDT Navigable Brain Biopsy Cannula (April 13, 2015)
  • K142344 — DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System (March 20, 2015)
  • K140705 — NAVIGABLE BRAIN BIOPSY CANNULA SET (December 5, 2014)

Other clearances for product code IZH

  • K203509 — SMART FINDER (July 14, 2021)
  • K202294 — Affirm Contrast Biopsy (October 5, 2020)
  • K191495 — Biopsy Positioner (July 3, 2019)
  • K161575 — Affirm Lateral Arm Upright Biopsy Accessory (August 10, 2016)
  • K161920 — Comfort Cover (July 15, 2016)
  • K153486 — Affirm Prone Biopsy System (April 1, 2016)
  • K152038 — MammoGRIP (December 22, 2015)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)

FDA data resources