Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K243897 · 2025-11-12

ApplicantETHICON, Inc.
Decision Date2025-11-12
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2025-11-12 under approval number K243897. 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 Absorbable Surgical Suture?

PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2025-11-12. It is manufactured by ETHICON, Inc.. The 510(k) number is K243897.

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

PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture received FDA 510(k) clearance on 2025-11-12, under approval number K243897.

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

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

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

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

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT06511414 Effect of Duramesh™ on Hernia Formation After Ileostomy Closure ACTIVE_NOT_RECRUITING NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07574086 Stratafix vs. PDS (Fascial Closure RCT) NOT_YET_RECRUITING NCT05538286 Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation RECRUITING

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

View all 30 devices →

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.

↑