SELECTOR ULTRASONIC SURGICAL ASPIRATOR— 510(k) K901974

Substantially Equivalent

Spembly Medical , Ltd.

FDA 510(k) clearance K901974 for SELECTOR ULTRASONIC SURGICAL ASPIRATOR, Substantially Equivalent on 1990-09-05. Applicant: Spembly Medical , Ltd..

Clearance details

Applicant
Spembly Medical , Ltd.
Product code
Code LFL
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
England, GB
Download summary PDFView on FDA.gov ↗

Adverse events under product code LFL

product code LFL
Death
29
Injury
1,046
Malfunction
21,642
Total
22,717

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.