FDA Product Code NEW: Suture, Surgical, Absorbable, Polydioxanone
Leading manufacturers include Ethicon, Inc., M/s. Meril Endo Surgery Private Limited. and Hyundae Meditech Co., Ltd..
FDA 510(k) Cleared Suture, Surgical, Absorbable, Polydioxanone Devices (Product Code NEW)
About Product Code NEW - Regulatory Context
510(k) Submission Activity
62 total 510(k) submissions under product code NEW since 2001, with 62 receiving FDA clearance (average review time: 147 days).
Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for NEW submissions have been consistent, averaging 140 days recently vs 148 days historically.
NEW devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →