COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM— 510(k) K122436

Name: FDA 510(k) clearance K122436
Creator: U.S. Food and Drug Administration
Published: 2012-11-02

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K122436 for COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM, Substantially Equivalent on 2012-11-02. Applicant: C.R. Bard, Inc.. Device class: 2.

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2012-08-10
Decision date: 2012-11-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Warwick, RI, US

Download summary PDF View on FDA.gov ↗

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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 K122436

K-number listed on FDA's recall record

Z-1682-2014 — Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1683-2014 — Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1684-2014 — Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1685-2014 — Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1686-2014 — Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1687-2014 — Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1688-2014 — Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1689-2014 — Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1690-2014 — Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1691-2014 — Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1692-2014 — Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1693-2014 — Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1694-2014 — Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1695-2014 — Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424
Z-1696-2014 — Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20140424

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122436.

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