Name: Predicase
Price: 199 USD

K-number	K243897
Device name	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
Applicant	ETHICON, Inc.
Product code	NEW
Device class	Class II
Decision date	Nov 12, 2025
Decision	Substantially Equivalent
Regulation	878.4840

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

Everything you need for a 510(k) submission. Nothing you don't.

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture