NEW · Class II · 21 CFR 878.4840

FDA Product Code NEW: Suture, Surgical, Absorbable, Polydioxanone

Leading manufacturers include Ethicon, Inc..

2
Total
2
Cleared
266d
Avg days
2022
Since

List of Suture, Surgical, Absorbable, Polydioxanone devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Nov 12, 2025
PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
K243897
Ethicon, Inc.
General & Plastic Surgery · 328d
Cleared Feb 22, 2022
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
K212380
Ethicon, Inc.
General & Plastic Surgery · 204d

How to use this database

This page lists all FDA 510(k) submissions for Suture, Surgical, Absorbable, Polydioxanone devices (product code NEW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →