510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161176Substantially Equivalent

ARTOURA Breast Tissue Expanders with Smooth Surface

Mentor Worldwide, LLC, Irvin CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161176 is the FDA 510(k) clearance record for ARTOURA Breast Tissue Expanders with Smooth Surface, cleared for Mentor Worldwide, LLC on under FDA product code LCJ (Tissue Expander And Accessories). FDA records list 12 510(k) clearances for Mentor Worldwide, LLC, from to . As of , FDA records show 2 recalls naming K161176.

Clearance record

Decision date
Received
(27 days to decision)
Product code
LCJ Tissue Expander And Accessories
Device class
Unclassified
Review panel
Unknown
Applicant
Mentor Worldwide, LLC 33 Technology Dr., Irvin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCJ

Trailing 12 months
1 clearance under product code LCJ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LCJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260