510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130817Substantially Equivalent

Ltn - Laparoscopic Surgical Mesh

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

K130817 is the FDA 510(k) clearance record for LTN - LAPAROSCOPIC SURGICAL MESH, a class II device, cleared for Lifecell Corp. on under FDA product code OXK (Mesh, Surgical, Collagen, Large Abdominal Wall Defects). FDA's definition for product code OXK reads: "For reinforcement of soft tissue where weakness exists in abdominal wall defects". FDA records list 15 510(k) clearances for Lifecell Corp., from to . As of , FDA records show no recalls naming K130817.

Clearance record

Decision date
Received
(23 days to decision)
Product code
OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Lifecell Corp. One Millennium Way, Branchburg NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXK

Trailing 12 months

FDA records hold no clearances under product code OXK in the trailing twelve months.

FDA records show no clearances under product code OXK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260