510(k) clearances

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

Sofradim Production · General, Plastic Surgery

K262443Substantially EquivalentTraditionalOWT
Open FDA's page for this record
Third party flag
N
City
Trévoux
Advisory committee description
General, Plastic Surgery
Address 1
116 Ave. Du Formans
Statement or summary
Summary
Product code
OWT
Zip code
01600
Applicant
Sofradim Production
Decision date
2026-10-16
Decision code
SESE
Country code
FR
Device name
Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)
Advisory committee
SU
Contact
Jhony Mallet
K number
K262443
Date received
2026-07-16
Review advisory committee
SU
Postal code
01600
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Mesh, Surgical, Absorbable, Abdominal Hernia
Medical specialty description
General, Plastic Surgery
Regulation number
878.3300
Device class
2
Registration number
9615742, 3010187263, 1213643, 3006082230, 3009514842, 3003910212, 3005636544, 3010383847, 1319639, 3009337401, 1223089, 3006174295
FEI number
3003521774, 3010187263, 1213643, 1000138054, 3009514842, 3003910212, 3005636544, 3010383847, 1000120505, 3006082230, 3009337401, 3006174295
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.