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OXC — Mesh, Surgical, Absorbable, Staple Line Reinforcement Class II

FDA Device Classification

Classification Details

Product Code
OXC
Device Class
Class II
Regulation Number
878.3300
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Definition

For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252906ethicon endo-surgeryECHELON ENDOPATH Staple Line Reinforcement (ECH60R)January 9, 2026
K231603standard bariatricsStandard Staple-Line Reinforcement (SSLR23)October 6, 2023
K221343ethicon endo-surgeryECHELON ENDOPATH Staple Line ReinforcementSeptember 16, 2022
K221487gunze limitedNEOVEIL Staple Line ReinforcementAugust 26, 2022
K190937ethicon endo-surgeryEchelon Endopath Staple Line ReinforcementOctober 14, 2019
K181940w.l. gore and associatesGORE SEAMGUARD Bioabsorbable Staple Line ReinforcementAugust 17, 2018
K150551w.l. gore and associatesGORE SEAMGUARD ReinforcementMarch 30, 2015
K130997gunze limitedNEOVEILNovember 15, 2013
K131658w.l. gore and associatesGORE SEAMGUARD REINFORCEMENTSeptember 6, 2013