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FDA 510(k)

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture

K-Number: K212380 · 2022-02-22

ApplicantETHICON, Inc.
Decision Date2022-02-22
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2022-02-22 under approval number K212380. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture?

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture is a medical device that received FDA 510(k) clearance on 2022-02-22. It is manufactured by ETHICON, Inc.. The 510(k) number is K212380.

When was PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture approved by the FDA?

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture received FDA 510(k) clearance on 2022-02-22, under approval number K212380.

What company makes PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture?

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture is manufactured by ETHICON, Inc..

What is the FDA product code for PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture?

The FDA product code for PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture is NEW.

Related Clinical Trials

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Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by ETHICON, Inc.

K161726E-Pack Procedure Kit K170767Surgical Stainless Steel Suture, Stainless Steel Suture K172089PROLENE Soft Polypropylene Mesh K163152PROLENE Soft Polypropylene Mesh K181652Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture K181151GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System

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Related Devices (Code: NEW)

K160705Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,Y. Jacobs Medical, Inc. K160761DW-1CDongwon Medical Co., Ltd. K150553FilblocAssut Europe K161737RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX UndyedMyco Medical K172602MiracuFeeltech Co., Ltd. K181582DemeTECH DemeDIOX absorbable surgical sutureDemetech Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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