Versatex Monofilament Mesh— 510(k) K150091
Substantially EquivalentSofradim Production
FDA 510(k) clearance K150091 for Versatex Monofilament Mesh, Substantially Equivalent on 2015-05-26. Applicant: Sofradim Production. Device class: 2.
Clearance details
- Applicant
- Sofradim Production
- Product code
- Code FTL
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trévoux, FR
Recent devices under product code FTL
view allMore clearances from Sofradim Production
view all- K243315 — ProGrip Self-Gripping Polypropylene Mesh
- K233661 — Transorb Self-Gripping Resorbable Mesh
- K232373 — Progrip Self-Gripping Polypropylene Mesh
- K223218 — Parietene Macroporous Mesh
- K220586 — Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
Adverse events under product code FTL
product code FTL- Death
- 317
- Injury
- 66,072
- Malfunction
- 1,273
- Other
- 3
- Total
- 67,665
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K150091
K-number listed on FDA's recall record- Z-2427-2018 — LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
- Z-1523-2018 — Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150091.
Data sourced from openFDA. This site is unofficial and independent of the FDA.