OOD

Surgical Film

Product code

OOD

Device name

Surgical Film

Device class

Class 2

21 CFR

21 CFR 878.3300

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Implant

Flag

Life-sustaining / life-supporting

510(k) clearances (last 3 years)

13

FDA classification 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.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-04-09.

1 summaries are archived here for direct download.