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FDA 510(k)

Natrelle 133S Tissue Expanders

K-Number: K254126 · 2026-01-16

ApplicantAbbVie
Decision Date2026-01-16
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

Natrelle 133S Tissue Expanders is a medical device manufactured by AbbVie. It received FDA 510(k) clearance on 2026-01-16 under approval number K254126. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Natrelle 133S Tissue Expanders?

Natrelle 133S Tissue Expanders is a medical device that received FDA 510(k) clearance on 2026-01-16. It is manufactured by AbbVie. The 510(k) number is K254126.

When was Natrelle 133S Tissue Expanders approved by the FDA?

Natrelle 133S Tissue Expanders received FDA 510(k) clearance on 2026-01-16, under approval number K254126.

What company makes Natrelle 133S Tissue Expanders?

Natrelle 133S Tissue Expanders is manufactured by AbbVie.

What is the FDA product code for Natrelle 133S Tissue Expanders?

The FDA product code for Natrelle 133S Tissue Expanders is LCJ.

Related Clinical Trials

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Related Devices (Code: LCJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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