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FDA 510(k)

Natrelle 133S Tissue Expander

K-Number: K182054 · 2018-08-29

ApplicantAllergan
Decision Date2018-08-29
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

Natrelle 133S Tissue Expander is a medical device manufactured by Allergan. It received FDA 510(k) clearance on 2018-08-29 under approval number K182054. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Natrelle 133S Tissue Expander?

Natrelle 133S Tissue Expander is a medical device that received FDA 510(k) clearance on 2018-08-29. It is manufactured by Allergan. The 510(k) number is K182054.

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

Natrelle 133S Tissue Expander received FDA 510(k) clearance on 2018-08-29, under approval number K182054.

What company makes Natrelle 133S Tissue Expander?

Natrelle 133S Tissue Expander is manufactured by Allergan.

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

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

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Related Devices (Code: LCJ)

K161483Unger Quad InjectorStradis Healthcare K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC K152496CPX 4 Breast Tissue ExpanderMentor Worldwide, LLC K180826Natrelle 133 Plus MICROCELL Tissue ExpanderAllergan K182335CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC K211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLC

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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