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FDA 510(k)

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device

K-Number: K192144 · 2020-03-25

ApplicantETHICON, Inc.
Decision Date2020-03-25
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device is a medical device manufactured by ETHICON, Inc.. It received FDA 510(k) clearance on 2020-03-25 under approval number K192144. 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 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device?

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device is a medical device that received FDA 510(k) clearance on 2020-03-25. It is manufactured by ETHICON, Inc.. The 510(k) number is K192144.

When was STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device approved by the FDA?

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device received FDA 510(k) clearance on 2020-03-25, under approval number K192144.

What company makes STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device?

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device is manufactured by ETHICON, Inc..

What is the FDA product code for STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device?

The FDA product code for STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device is NEW.

Related Clinical Trials

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Related PubMed Literature

PMID: 42105288 Evaluating regulatory oversight through major Expert review of medical devices (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 41273038 Optimization of the Nonclinical Biological Evaluation of Medical Devices Using Toxicologic Pathology Best Practices. Advanced healthcare materials (2026)

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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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