AlloX2 Pro Tissue Expanders
K-Number: K214124 · 2023-06-08
Device Summary
AlloX2 Pro Tissue Expanders is a medical device manufactured by Sientra, Inc.. It received FDA 510(k) clearance on 2023-06-08 under approval 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. It is manufactured by Sientra, Inc.. The 510(k) number is K214124.
When was AlloX2 Pro Tissue Expanders approved by the FDA?
AlloX2 Pro Tissue Expanders received FDA 510(k) clearance on 2023-06-08, under approval number K214124.
What company makes AlloX2 Pro Tissue Expanders?
AlloX2 Pro Tissue Expanders is manufactured by Sientra, Inc..
What is the FDA product code for AlloX2 Pro Tissue Expanders?
The FDA product code for AlloX2 Pro Tissue Expanders is LCJ.
Related Clinical Trials
Other Devices by Sientra, Inc.
Related Devices (Code: LCJ)
K161483Unger Quad InjectorStradis Healthcare
K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC
K152496CPX 4 Breast Tissue ExpanderMentor Worldwide, LLC
K180826Natrelle 133 Plus MICROCELL Tissue ExpanderAllergan
K182335CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC
K182054Natrelle 133S Tissue ExpanderAllergan
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.