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510(k) K254126

Natrelle 133S Tissue Expanders by AbbVie — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2026
Date Received
December 19, 2025
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 AbbVie

  • K142792 — AbbVie NJ (January 14, 2015)
  • K142793 — AbbVie PEG (January 14, 2015)
  • K142816 — AbbVie J (January 14, 2015)
  • K133129 — ABBVIE NJ (June 19, 2014)
  • K133087 — ABBVIE PEG (June 19, 2014)
  • K133096 — ABB VIE J (June 18, 2014)

Other clearances for product code LCJ

  • 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)
  • K161483 — Unger Quad Injector (October 31, 2016)