Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)— 510(k) K262443

Name: FDA 510(k) clearance K262443
Creator: U.S. Food and Drug Administration
Published: 2026-10-16

Substantially Equivalent

Sofradim Production

FDA 510(k) clearance K262443 for Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030), Substantially Equivalent on 2026-10-16. Applicant: Sofradim Production. Device class: 2.

Clearance details

Applicant: Sofradim Production
Product code: Product code OWT
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2026-07-16
Decision date: 2026-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trévoux, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWT

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K261543 — Phasix ST Parastomal Hernia Mesh2026-09-28
K243241 — Phasix ST Umbilical Hernia Patch2025-02-19
K233661 — Transorb Self-Gripping Resorbable Mesh2024-02-13
K191749 — TIGR Matrix Surgical Mesh, TIGR Surgical Mesh2020-03-26
K191773 — GORE BIO-A Tissue Reinforcement2019-07-31

More clearances from Sofradim Production

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K253956 — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)2026-05-21
K250869 — Parietene Macroporous Mesh (PPM5050 )2025-04-23
K243315 — ProGrip Self-Gripping Polypropylene Mesh2025-01-17
K232373 — Progrip Self-Gripping Polypropylene Mesh2024-01-18
K223218 — Parietene Macroporous Mesh2022-12-02

Adverse events under product code OWT

product code OWT

Death: 3
Injury: 396
Total: 399

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.