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FDA 510(k)

Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)

K-Number: K262443 · 2026-10-16

ApplicantSofradim Production
Decision Date2026-10-16
Product CodeOWT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2026-10-16 under 510(k) number K262443. 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 (TSB1510 / TSB2020 / TSB3030 / TSB4030)?

Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) is a medical device that received FDA 510(k) clearance on 2026-10-16. The listed applicant is Sofradim Production. The 510(k) number is K262443.

When did Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) receive FDA 510(k) clearance?

Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) received FDA 510(k) clearance on 2026-10-16, under 510(k) number K262443.

Who is the listed applicant for Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)?

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 (TSB1510 / TSB2020 / TSB3030 / TSB4030)?

The FDA product code for Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) is OWT.

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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 MeshK233661Transorb™ Self-Gripping Resorbable MeshK232373Progrip™ Self-Gripping Polypropylene MeshK223218Parietene Macroporous Mesh

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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.

K261543Phasix ST Parastomal Hernia MeshDavol, Inc., A Subsidiary of C.R. Bard, Inc.K243241Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc.K233661Transorb™ Self-Gripping Resorbable MeshSofradim ProductionK191749TIGR 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.

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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