Onflex Mesh— 510(k) K251955

Name: FDA 510(k) clearance K251955
Creator: U.S. Food and Drug Administration
Published: 2025-07-24

Substantially Equivalent

Davol Inc., Subsidiary of C. R. Bard, Inc.

FDA 510(k) clearance K251955 for Onflex Mesh, Substantially Equivalent on 2025-07-24. Applicant: Davol Inc., Subsidiary of C. R. Bard, Inc.. Device class: 2.

Clearance details

Applicant: Davol Inc., Subsidiary of C. R. Bard, Inc.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2025-06-25
Decision date: 2025-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Warwick, RI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTL

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K253956 — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)2026-05-21
K253125 — Parietene Flat Sheet Mesh2025-10-24
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

More clearances from Davol Inc., Subsidiary of C. R. Bard, Inc.

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K241250 — 3DMax Light Mesh2024-06-14
K233402 — Bard 3DMax Mesh2023-11-01

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.