FDA Product Code OWR: Mesh, Surgical, Non-absorbable, Facial Implants For Plastic Surgery
For Reinforcement Of Soft Tissue Where Weakness Exists In Facial Plastic Surgery.
Leading manufacturers include Shanghai Suokang Medical Implants Co., Ltd..
1
Total
1
Cleared
1139d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Mesh, Surgical, Non-absorbable, Facial Implants For Plastic Surgery Devices (Product Code OWR)
1 devices
About Product Code OWR - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code OWR since 2023, with 1 receiving FDA clearance (average review time: 1139 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
OWR devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →