Natrelle 133S Tissue Expanders— 510(k) K254126

Name: FDA 510(k) clearance K254126
Creator: U.S. Food and Drug Administration
Published: 2026-01-16

Substantially Equivalent

AbbVie

FDA 510(k) clearance K254126 for Natrelle 133S Tissue Expanders, Substantially Equivalent on 2026-01-16. Applicant: AbbVie. Device class: Unclassified.

Clearance details

Applicant: AbbVie
Product code: Code LCJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-12-19
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCJ

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K242963 — MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs2025-04-24
K243836 — Mentor CPX 4 PLUS Enhance Breast Tissue Expander2025-01-12
K241918 — MENTOR CPX4 PLUS Enhance Breast Tissue Expander2024-08-02
K211676 — Motiva Flora SmoothSilk Tissue Expander2023-10-13
K214124 — AlloX2 Pro Tissue Expanders2023-06-08

Adverse events under product code LCJ

product code LCJ

Injury: 2,704
Other: 2
Total: 2,706

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.