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510(k) K130813

MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS by Mentor Corp. — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2013
Date Received
March 25, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Mentor Corp.

  • K053414 — MENTOR NOVASILK MESH (December 27, 2005)
  • K050008 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (June 3, 2005)
  • K042851 — MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT (November 9, 2004)
  • K040959 — MENTOR GENESIS PENILE PROSTHESIS (October 29, 2004)
  • K031767 — MENTOR OBTAPE TRANS-OBTURATOR TAPE (July 17, 2003)
  • K011493 — MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRA (October 1, 2002)
  • K011500 — MENTOR CONTOUR PROFILE TISSUE EXPANDER (December 3, 2001)
  • K004005 — MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENES (October 12, 2001)
  • K010709 — MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (April 23, 2001)
  • K003873 — MENTOR SELF-CATH CLOSED SYSTEM (March 29, 2001)

Other clearances for product code LCJ

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  • K242963 — MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (April 24, 2025)
  • K243836 — Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (January 12, 2025)
  • K241918 — MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander (August 2, 2024)
  • K211676 — Motiva Flora SmoothSilk Tissue Expander (October 13, 2023)
  • K214124 — AlloX2 Pro Tissue Expanders (June 8, 2023)
  • K221127 — Sientra, inc. Portfinder (May 10, 2023)
  • K180826 — Natrelle 133 Plus MICROCELL Tissue Expander (December 21, 2018)
  • K182335 — CPX 4 Breast Tissue Expander with Smooth Surface (September 25, 2018)
  • K182054 — Natrelle 133S Tissue Expander (August 29, 2018)