MODULARIS VARIOSTAR— 510(k) K070799

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K070799 for MODULARIS VARIOSTAR, Substantially Equivalent on 2007-11-01. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant
Siemens Medical Solutions USA, Inc.
Product code
Code LNS
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Malvern, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LNS

product code LNS
Death
4
Injury
320
Total
324

Source: openFDA MAUDE database, through . 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.