PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES— 510(k) K072951

Clearance details

Applicant

Sofradim Production

Product code

Code OTP

Device class

Class 3

Regulation

21 CFR 884.5980

Advisory panel

Obstetrics/Gynecology

Date received

2007-10-18

Decision date

2007-12-19

Decision

Substantially Equivalent

Clearance type

Special

Location

Norwalk, CT, US

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• K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM2011-09-08

• K253956 — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)2026-05-21
• 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

Injury

1,061

Total

1,061

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 →