FDA Device Intelligence
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Kirwan

KIRWAN SURGICAL PRODUCTS LLC · Model 41-6115 · UDI-DI 00841019107751

HQP Prescription
1
510(k) clearances
106
Adverse events
3
Recalls
19
Facilities

Description

Disposable Cautery Variable Low Temperature, Loop Tip

Recalls

DateFirmReason
2018-07-19Beaver VisitecA small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may c
2004-06-29Aaron Medical Industries, Inc.The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.
2004-06-29Aaron Medical Industries, Inc.The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.