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FDA 510(k)

NATRELLE INSPIRA Single Use Sizers for Gel Implants

K-Number: K203229 · 2021-06-02

ApplicantAllergan
Decision Date2021-06-02
Product CodeMRD
DecisionSubstantially Equivalent

Device Summary

NATRELLE INSPIRA Single Use Sizers for Gel Implants is the device name listed in this FDA 510(k) record. The listed applicant is Allergan. It received FDA 510(k) clearance on 2021-06-02 under 510(k) number K203229. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NATRELLE INSPIRA Single Use Sizers for Gel Implants?

NATRELLE INSPIRA Single Use Sizers for Gel Implants is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is Allergan. The 510(k) number is K203229.

When did NATRELLE INSPIRA Single Use Sizers for Gel Implants receive FDA 510(k) clearance?

NATRELLE INSPIRA Single Use Sizers for Gel Implants received FDA 510(k) clearance on 2021-06-02, under 510(k) number K203229.

Who is the listed applicant for NATRELLE INSPIRA Single Use Sizers for Gel Implants?

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 INSPIRA Single Use Sizers for Gel Implants?

The FDA product code for NATRELLE INSPIRA Single Use Sizers for Gel Implants is MRD.

Related Clinical Trials

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Other records listing Allergan as applicant

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Related Devices (Code: MRD)

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.

K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLCK241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLCK200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc.K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva 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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