FDA 510(k) clearance · back to tracker
Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)
Sofradim Production cleared K262443 on 2026-10-16, decision: substantially equivalent
K-number
K262443
Sponsor
Sofradim Production
Device
Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-10-16
Product code
OWT
Advisory committee
General, Plastic Surgery
Medical specialty
General, Plastic Surgery
Regulation number
878.3300
Official FDA record
Open K262443on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.