Home › FOCUS SURGERY INC › Sonablate Insertion Pack
Sonablate Insertion Pack
FOCUS SURGERY INC · Model 403-02200-0014 · UDI-DI 00868108000267
PLP
Prescription
10
510(k) clearances
33
Adverse events (1 deaths)
1
Recalls
8
Facilities
Description
A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-08-14 | Edap 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.