Motiva Flora SmoothSilk Tissue Expander— 510(k) K211676

Name: FDA 510(k) clearance K211676
Creator: U.S. Food and Drug Administration
Published: 2023-10-13

Substantially Equivalent

Motiva USA, LLC

FDA 510(k) clearance K211676 for Motiva Flora SmoothSilk Tissue Expander, Substantially Equivalent on 2023-10-13. Applicant: Motiva USA, LLC. Device class: Unclassified.

Clearance details

Applicant: Motiva USA, LLC
Product code: Code LCJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2021-06-01
Decision date: 2023-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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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.