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FDA 510(k)

STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device

K-Number: K253572 · 2026-03-27

ApplicantETHICON, Inc.
Decision Date2026-03-27
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ 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 2026-03-27 under 510(k) number K253572. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device?

STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is ETHICON, Inc.. The 510(k) number is K253572.

When did STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device receive FDA 510(k) clearance?

STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device received FDA 510(k) clearance on 2026-03-27, under 510(k) number K253572.

Who is the listed applicant for STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ 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 PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device?

The FDA product code for STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device is GAW.

Related Clinical Trials

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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 DevicesK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture

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Related Devices (Code: GAW)

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.

K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLCK193530Deklene MAXXTeleflex Medical

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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