OXJ — Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects Class II

FDA Device Classification

FDA product code OXJ covers "Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
OXJ
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 in abdominal wall defects.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K161939molnlycke health care usAvance Abdominal Dressing KitNovember 17, 2016
K130852molnlycke health careAVANCE® FOAM ABDOMINAL DRESSING KITApril 14, 2014