510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153364Substantially Equivalent

Kerecis SecureMesh

Kerecis Limited, Isafjordur, IS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153364 is the FDA 510(k) clearance record for Kerecis SecureMesh, a class II device, cleared for Kerecis Limited on under FDA product code OXE (Mesh, Surgical, Collagen, Staple Line Reinforcement). FDA's definition for product code OXE reads: "For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures". FDA records list 11 510(k) clearances for Kerecis Limited, from to . As of , FDA records show no recalls naming K153364.

Clearance record

Decision date
Received
(273 days to decision)
Product code
OXE Mesh, Surgical, Collagen, Staple Line Reinforcement
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kerecis Limited Eyrargata 2, Isafjordur, IS
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXE

Trailing 12 months

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

FDA records show no clearances under product code OXE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXE, 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