OXC

Mesh, Surgical, Absorbable, Staple Line Reinforcement

Product code
OXC
Device name
Mesh, Surgical, Absorbable, Staple Line Reinforcement
Device class
Class 2
21 CFR
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
9

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-01-09.

NumberDecision dateApplicantDevice nameSummary
K2529062026-01-09Ethicon Endo-Surgery, LLCECHELON ENDOPATH Staple Line Reinforcement (ECH60R)PDF
K2316032023-10-06Standard Bariatrics, Inc.Standard Staple-Line Reinforcement (SSLR23)PDF

2 summaries are archived here for direct download.

Official FDA classification page: OXC
Classification and pathway per current FDA publications. Data from openFDA (CC0).