DeviceClearance

Product code OOD— General, Plastic Surgery

Phasix Mesh

Classification name
Surgical Film
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
13
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OOD under 21 CFR 878.3300, via openFDA

Market context for product code OOD

FDA has cleared 13 devices under product code OOD between 2007 and 2024, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OOD

Adverse events under product code OOD

product code OOD
Death
6
Injury
1,005
Total
1,011

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OOD

Data sourced from openFDA. This site is unofficial and independent of the FDA.