V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600— 510(k) K062896

Substantially Equivalent

Sanarus Medical, Inc.

FDA 510(k) clearance K062896 for V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600, Substantially Equivalent on 2007-01-03. Applicant: Sanarus Medical, Inc..

Clearance details

Applicant: Sanarus Medical, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2006-09-27
Decision date: 2007-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.