510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162752Substantially Equivalent

ARTIA Reconstructive Tissue Matrix Perforated

LifeCell Corp, Branchburg NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162752 is the FDA 510(k) clearance record for ARTIA Reconstructive Tissue Matrix Perforated, a class II device, cleared for Lifecell Corporation on under FDA product code FTM (Mesh, Surgical). FDA records list 15 510(k) clearances for Lifecell Corporation, from to . As of , FDA records show no recalls naming K162752.

Clearance record

Decision date
Received
(147 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Lifecell Corporation One Millennium Way, Branchburg NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTM

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