DeviceClearance

K150924

Substantially Equivalent

A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device

Applicant
Anchor Innovation Medical (A.I.M.)
Product code
GZB
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rockville, MD, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GZB

product code GZB
Death
4
Injury
1,879
Other
2
Total
1,885

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.