DeviceClearance

K934636

Substantially Equivalent

ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR

Applicant
Annex Medical, Inc.
Product code
FFL
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Eden Prairie, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FFL

product code FFL
Death
2
Injury
270
Malfunction
2,711
Other
2
Total
2,985

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.