VENTRALIGHT ST MESH— 510(k) K101851

Name: FDA 510(k) clearance K101851
Creator: U.S. Food and Drug Administration
Published: 2010-07-15

Substantially Equivalent

Davol Inc., Sub. C. R. Bard, Inc.

FDA 510(k) clearance K101851 for VENTRALIGHT ST MESH, Substantially Equivalent on 2010-07-15. Applicant: Davol Inc., Sub. C. R. Bard, Inc.. Device class: 2.

Clearance details

Applicant: Davol Inc., Sub. C. R. Bard, Inc.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2010-07-01
Decision date: 2010-07-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Warwick, RI, US

Download summary PDF View on FDA.gov ↗

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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

More clearances from Davol Inc., Sub. C. R. Bard, Inc.

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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 →

Recalls naming K101851

K-number listed on FDA's recall record

Z-2412-2012 — Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20120904
Z-2413-2012 — Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20120904

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101851.

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