BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160— 510(k) K092032

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

2009-07-06

Decision date

2009-12-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warwick, RI, US

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• K101851 — VENTRALIGHT ST MESH2010-07-15
• K081010 — BARD 3DMAX MESH2008-10-07
• K061754 — BARD COMPOSITE L/P MESH2006-10-23
• K061314 — BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH2006-06-02
• K051848 — SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 01130792005-08-11

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 →

• Z-0191-2015 — Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.Class II·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·20141008

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092032.