DeviceClearance

Product code OWR— General, Plastic Surgery

Tisuthes e-PTFE Surgical Patch

Classification name
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

“For reinforcement of soft tissue where weakness exists in facial plastic surgery.”

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

Market context for product code OWR

FDA has cleared 1 device under product code OWR, all in 2023, filed by 1 applicant company. 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.

Top applicants under product code OWR

Recent clearances under product code OWR

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