SANARUS V2 TREATMENT SYSTEM— 510(k) K073533

Substantially Equivalent

Sanarus Medical, Inc.

FDA 510(k) clearance K073533 for SANARUS V2 TREATMENT SYSTEM, Substantially Equivalent on 2008-02-07. Applicant: Sanarus Medical, Inc..

Clearance details

Applicant: Sanarus Medical, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2007-12-17
Decision date: 2008-02-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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.