AlloX2 Pro Tissue Expanders— 510(k) K214124

Name: FDA 510(k) clearance K214124
Creator: U.S. Food and Drug Administration
Published: 2023-06-08

Substantially Equivalent

Sientra, Inc.

FDA 510(k) clearance K214124 for AlloX2 Pro Tissue Expanders, Substantially Equivalent on 2023-06-08. Applicant: Sientra, Inc.. Device class: Unclassified.

Clearance details

Applicant: Sientra, Inc.
Product code: Code LCJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2021-12-30
Decision date: 2023-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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K211676 — Motiva Flora SmoothSilk Tissue Expander2023-10-13

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Adverse events under product code LCJ

product code LCJ

Injury: 2,704
Other: 2
Total: 2,706

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.