OOD · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.3300
Classification
FDA Product Code
OOD
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.3300
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N
Definition
To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.