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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 the device name listed in this FDA 510(k) record. The listed applicant is Allergan. It received FDA 510(k) clearance on 2018-08-29 under 510(k) 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. The listed applicant is Allergan. The 510(k) number is K182054.

When did Natrelle 133S Tissue Expander receive FDA 510(k) clearance?

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

Who is the listed applicant for Natrelle 133S Tissue Expander?

The FDA 510(k) record lists Allergan as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Allergan as applicant

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Related Devices (Code: LCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254126Natrelle 133S Tissue ExpandersAbbVieK242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLCK243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLCK214124AlloX2 Pro Tissue ExpandersSientra, Inc.

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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