DeviceClearance

Product code OWT— General, Plastic Surgery

Phasix ST Mesh

Classification name
Mesh, Surgical, Absorbable, Abdominal Hernia
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
11
First cleared
Most recent

FDA classification definition

“For reinforcement of soft tissue where weakness exists during hernia repair.”

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

Market context for product code OWT

FDA has cleared 11 devices under product code OWT between 2003 and 2025, filed by 6 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 OWT

Adverse events under product code OWT

product code OWT
Death
3
Injury
396
Total
399

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 OWT

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