Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh— 510(k) K142908

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

2014-10-06

Decision date

2014-11-14

Decision

Substantially Equivalent

Clearance type

Special

Location

Trévoux, FR

• K253956 — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)2026-05-21
• K253125 — Parietene Flat Sheet Mesh2025-10-24
• K251955 — Onflex Mesh2025-07-24
• K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped2025-06-12
• K250869 — Parietene Macroporous Mesh (PPM5050 )2025-04-23

• K243315 — ProGrip Self-Gripping Polypropylene Mesh2025-01-17
• K233661 — Transorb Self-Gripping Resorbable Mesh2024-02-13
• K232373 — Progrip Self-Gripping Polypropylene Mesh2024-01-18
• K223218 — Parietene Macroporous Mesh2022-12-02
• K220586 — Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh2022-06-22

Death

317

Injury

66,072

Malfunction

1,273

Other

3

Total

67,665

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 →

• Z-0461-2019 — Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side of the design is completely covered with the hydrophilic film. On the opposite side, only the two-dimensional central band is coated with the absorbable hydrophilic film. The film extends 5 mm over the external edge of the reinforcement. The Parietex composite parastomal mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.Class II·Terminated·Covidien LLC·20181005

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142908.