inforMED
FEBClass II

Accessories, Cleaning, For Endoscope

Gastroenterology, Urology · 21 CFR 876.1500

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

MDR events5,046All time
Recalls40All time
Registered firms61Currently listed
510(k) clearances57All time

Recent MDR events

5,046 adverse event reports on file

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Event type breakdown

Malfunction4,407
Injury402
Unspecified151
Other64
Death22

Most-reported manufacturers

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Aizu Olympus Co., Ltd.2,683Olympus Medical Systems Corp.1,200Medivators250Advanced Sterilization Products187Medivators Inc.143Custom Ultrasonics Inc.81Medivators, Inc.73Medivators Inc71

Recalls

40 recall events for this product code

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Registered firms

61 firms currently registered for this product code

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510(k) clearances

57 clearances for this product code

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