Parietene Flat Sheet Mesh— 510(k) K253125

Name: FDA 510(k) clearance K253125
Creator: U.S. Food and Drug Administration
Published: 2025-10-24

Substantially Equivalent

Medtronic - Sofradim Production

FDA 510(k) clearance K253125 for Parietene Flat Sheet Mesh, Substantially Equivalent on 2025-10-24. Applicant: Medtronic - Sofradim Production. Device class: 2.

Clearance details

Applicant: Medtronic - Sofradim Production
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2025-09-25
Decision date: 2025-10-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Trévoux, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTL

view all

K253956 — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)2026-05-21
K251955 — Onflex Mesh2025-07-24
K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped2025-06-12
K250869 — Parietene Macroporous Mesh (PPM5050 )2025-04-23
K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped2025-04-09

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, 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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.