Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Allergan. It received FDA 510(k) clearance on 2021-06-02 under approval 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. It is manufactured by Allergan. The 510(k) number is K203229.

When was NATRELLE INSPIRA Single Use Sizers for Gel Implants approved by the FDA?

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

What company makes NATRELLE INSPIRA Single Use Sizers for Gel Implants?

NATRELLE INSPIRA Single Use Sizers for Gel Implants is manufactured by Allergan.

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

NCT07343141 To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds NOT_YET_RECRUITING NCT07595185 Effects of Accelerated rTMS on Sleep Architecture in Chronic Insomnia Disorder NOT_YET_RECRUITING NCT03795675 CI Following VS Removal or Labyrinthectomy ACTIVE_NOT_RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT04251377 Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection ACTIVE_NOT_RECRUITING NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED

Other Devices by Allergan

K180826Natrelle 133 Plus MICROCELL Tissue Expander K182054Natrelle 133S Tissue Expander DEN170086TrueTear Intranasal Tear Neurostimulator K193589TrueTear Intranasal Tear Neurostimulator PMA P020056Prosthesis, breast, noninflatable, internal, silicone gel-filled PMA P110033Implant, dermal, for aesthetic use

View all 10 devices →

Related Devices (Code: MRD)

K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLC K200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc. K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, 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.

↑