510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233661Substantially Equivalent

Transorb™ Self-Gripping Resorbable Mesh

Sofradim Production, Trévoux, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233661 is the FDA 510(k) clearance record for Transorb™ Self-Gripping Resorbable Mesh, a class II device, cleared for Sofradim Production on under FDA product code OWT (Mesh, Surgical, Absorbable, Abdominal Hernia). FDA's definition for product code OWT reads: "For reinforcement of soft tissue where weakness exists during hernia repair". FDA records list 42 510(k) clearances for Sofradim Production, from to . As of , FDA records show no recalls naming K233661.

Clearance record

Decision date
Received
(90 days to decision)
Product code
OWT Mesh, Surgical, Absorbable, Abdominal Hernia
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sofradim Production 116 Ave. Du Formans, Trévoux, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWT

Trailing 12 months

FDA records hold no clearances under product code OWT in the trailing twelve months.

FDA records show no clearances under product code OWT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OWT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260