inforMED
NTBClass II

System, Ablation, Ultrasound And Accessories

General, Plastic Surgery · 21 CFR 878.4400

Intended for use as a surgical tool for coagulation and ablation of soft tissue. This differs from the description in the regulation in that this device is not intended to cut tissue and this device uses high intensity ultrasound energy instead of electrosurgery or electrocautery.

MDR events34All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances6All time

Recent MDR events

34 adverse event reports on file

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Event type breakdown

Malfunction14
Injury12
Death5
Other3

Most-reported manufacturers

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St. Jude Medical25Epicor Medical, Inc.5Epicor Medical Inc.1Epicor Medical, Inc1St. Jude Medical, Inc1St. Jude Medical, Inc.1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

3 firms currently registered for this product code

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510(k) clearances

6 clearances for this product code

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