inforMED
ODAClass II

Endoscopic Central Control Unit

Gastroenterology, Urology · 21 CFR 876.1500

To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.

MDR events28All time
Recalls0All time
Registered firms50Currently listed
510(k) clearances18All time

Recent MDR events

28 adverse event reports on file

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Event type breakdown

Malfunction24
Injury4

Most-reported manufacturers

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Shirakawa Olympus Co., Ltd.20Stryker Endoscopy San Jose5Covidien1Oklahoma City Manufacturing Site1Olympus Medical Systems Corp.1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

50 firms currently registered for this product code

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510(k) clearances

18 clearances for this product code

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