DeviceClearance

Natrelle 133 Plus Tissue Expander— 510(k) K143354

Substantially Equivalent

Allergan, Inc.

FDA 510(k) clearance K143354 for Natrelle 133 Plus Tissue Expander, Substantially Equivalent on 2015-08-20. Applicant: Allergan, Inc.. Device class: Unclassified.

Clearance details

Applicant
Allergan, Inc.
Product code
Code LCJ
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView 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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K143354

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143354.

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