PLPClass II

High Intensity Ultrasound System For Prostate Tissue Ablation

Gastroenterology, Urology · 21 CFR 876.4340

Prostate tissue ablation

MDR events33All time

Recalls1All time

Registered firms24Currently listed

510(k) clearances13All time

Recent MDR events

33 adverse event reports on file

Event type breakdown

Injury31

Death1

Malfunction1

Most-reported manufacturers

Focus Surgery, Inc.24 Edap Technomed Inc.1 Edap Tms1 Edap Tms France1 Edap Tms France Sa1 Focus Surgery, Inc1 Insightec Ltd.1 Profound Medical Inc1

Recalls

1 recall events for this product code

Edap Technomed Inc.
TerminatedUnknown
Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation
The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining devices in the U.S. until supporting clinical data can be submitted and evaluated by FDA.
Z-0049-2018 · View FDA record ↗

Registered firms

24 firms currently registered for this product code

510(k) clearances

13 clearances for this product code