FDA 510(k) clearance · back to tracker
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
ETHICON, Inc. cleared K243897 on 2025-11-12, decision: substantially equivalent
K-number
K243897
Sponsor
ETHICON, Inc.
Device
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
Class
Class II
Decision
Substantially Equivalent
Decision date
2025-11-12
Product code
NEW
Advisory committee
General, Plastic Surgery
Medical specialty
General, Plastic Surgery
Regulation number
878.4840
Official FDA record
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FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.