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The Tracker / October 2026 / K262443

510(k) cleared

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

Sofradim Production · Oct 16, 2026 · K262443

FDA cleared the Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) from Sofradim Production on Oct 16, 2026 under K262443, a traditional 510(k). The device falls under product code OWT, Mesh, Surgical, Absorbable, Abdominal Hernia, regulated at 21 CFR 878.3300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 16, 2026. The decision came 92 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sofradim Production has one other decision in the tracker over the last 12 months: K253956 (ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)).

Questions & Answers

What did FDA clear under K262443?

K262443 is the FDA 510(k) for Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030), submitted by Sofradim Production. FDA's decision date was Oct 16, 2026, under product code OWT (Mesh, Surgical, Absorbable, Abdominal Hernia).

Who makes the Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)?

Sofradim Production, based in Trévoux, is the applicant of record for K262443.

How long did the K262443 review take?

FDA received the submission on Jul 16, 2026 and issued its decision on Oct 16, 2026, 92 days later.

← All decisions in October 2026

Sources