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Sonablate

FOCUS SURGERY INC · Model 202-17000-0012 · UDI-DI 00868108000229

PLP Prescription
10
510(k) clearances
33
Adverse events (1 deaths)
1
Recalls
8
Facilities

Description

Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy.

Recalls

DateFirmReason
2017-08-14Edap Technomed Inc.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 dev

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.