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FDA 510(k)

Sientra, inc. Portfinder

K-Number: K221127 · 2023-05-10

ApplicantSientra, Inc.
Decision Date2023-05-10
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

Sientra, inc. Portfinder is the device name listed in this FDA 510(k) record. The listed applicant is Sientra, Inc.. It received FDA 510(k) clearance on 2023-05-10 under 510(k) number K221127. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sientra, inc. Portfinder?

Sientra, inc. Portfinder is a medical device that received FDA 510(k) clearance on 2023-05-10. The listed applicant is Sientra, Inc.. The 510(k) number is K221127.

When did Sientra, inc. Portfinder receive FDA 510(k) clearance?

Sientra, inc. Portfinder received FDA 510(k) clearance on 2023-05-10, under 510(k) number K221127.

Who is the listed applicant for Sientra, inc. Portfinder?

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

What is the FDA product code for Sientra, inc. Portfinder?

The FDA product code for Sientra, inc. Portfinder is LCJ.

Other records listing Sientra, Inc. as applicant

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.

K214124AlloX2 Pro Tissue ExpandersK200706Sientra OPUS Silicone Gel Breast Implant Sizer

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

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

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