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FDA 510(k)

Transorb™ Self-Gripping Resorbable Mesh

K-Number: K233661 · 2024-02-13

ApplicantSofradim Production
Decision Date2024-02-13
Product CodeOWT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Transorb™ Self-Gripping Resorbable Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2024-02-13 under 510(k) number K233661. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transorb™ Self-Gripping Resorbable Mesh?

Transorb™ Self-Gripping Resorbable Mesh is a medical device that received FDA 510(k) clearance on 2024-02-13. The listed applicant is Sofradim Production. The 510(k) number is K233661.

When did Transorb™ Self-Gripping Resorbable Mesh receive FDA 510(k) clearance?

Transorb™ Self-Gripping Resorbable Mesh received FDA 510(k) clearance on 2024-02-13, under 510(k) number K233661.

Who is the listed applicant for Transorb™ Self-Gripping Resorbable Mesh?

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

What is the FDA product code for Transorb™ Self-Gripping Resorbable Mesh?

The FDA product code for Transorb™ Self-Gripping Resorbable Mesh is OWT.

Related Clinical Trials

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NCT05424484Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia OccurrenceACTIVE_NOT_RECRUITINGNCT06449378Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral HerniaACTIVE_NOT_RECRUITINGNCT07649434Effect of Biologic vs Synthetic Mesh on Chronic Pain After Laparoscopic Repair of Contralateral Asymptomatic Hernia in Patients With Unilateral Symptomatic Inguinal HerniaNOT_YET_RECRUITING

Other records listing Sofradim Production 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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)K250869Parietene™ Macroporous Mesh (PPM5050 )K243315ProGrip™ Self-Gripping Polypropylene MeshK232373Progrip™ Self-Gripping Polypropylene MeshK223218Parietene Macroporous MeshK220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh

View all 11 devices →

Related Devices (Code: OWT)

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.

K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific ABK191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc.K173143Phasix ST MeshC.R. Bard, Inc.K163005TIGR Matrix Surgical MeshNovus Scientific AB

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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