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OXN

Mesh, Surgical, Collagen, Fistula

Product code
OXN
Device name
Mesh, Surgical, Collagen, Fistula
Device class
Class 2
21 CFR
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification definition

For reinforcement of soft tissue where weakness exists during the repair of fistulas.

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

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