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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 the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2020-03-25 under 510(k) 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. The listed applicant is ETHICON, Inc.. The 510(k) number is K192144.

When did STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device receive FDA 510(k) clearance?

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

Who is the listed applicant for STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device?

The FDA 510(k) record lists ETHICON, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06664788A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open SurgeryRECRUITINGNCT04829058GYNEMESH PS Mesh Post Marketing Clinical Follow-Up StudyRECRUITINGNCT04829175Ethicon Pelvic Mesh Post Market Clinical Follow-up RegistryRECRUITINGNCT04829357Post Market Clinical Follow-up Study on TVT ABBREVO® Continence SystemRECRUITINGNCT04829994Post-Market Clinical Follow-Up onTVT EXACT® Continence SystemACTIVE_NOT_RECRUITING

Other records listing ETHICON, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA N12159Agent, absorbable hemostatic, non-collagen basedPMA P880047Barrier, absorbable, adhesionPMA P240035Agent, absorbable hemostatic, collagen with polymeric additivesK253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureK252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesK253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device

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Related Devices (Code: NEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.

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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