VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH

K851086 · ETHICON, Inc. · FTM · May 21, 1985 · General, Plastic Surgery

Device Facts

Record IDK851086
Device NameVICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH
ApplicantETHICON, Inc.
Product CodeFTM · General, Plastic Surgery
Decision DateMay 21, 1985
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.3300
Device ClassClass 2

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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