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FDA 510(k)

AlloX2 Pro Tissue Expanders

K-Number: K214124 · 2023-06-08

ApplicantSientra, Inc.
Decision Date2023-06-08
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

AlloX2 Pro Tissue Expanders is the device name listed in this FDA 510(k) record. The listed applicant is Sientra, Inc.. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K214124. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AlloX2 Pro Tissue Expanders?

AlloX2 Pro Tissue Expanders is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Sientra, Inc.. The 510(k) number is K214124.

When did AlloX2 Pro Tissue Expanders receive FDA 510(k) clearance?

AlloX2 Pro Tissue Expanders received FDA 510(k) clearance on 2023-06-08, under 510(k) number K214124.

Who is the listed applicant for AlloX2 Pro Tissue Expanders?

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 AlloX2 Pro Tissue Expanders?

The FDA product code for AlloX2 Pro Tissue Expanders 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.

K221127Sientra, inc. PortfinderK200706Sientra 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, LLCK221127Sientra, inc. PortfinderSientra, 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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