MULTILASE 2500 A— 510(k) K920708

Substantially Equivalent

Teknomed, Inc.

FDA 510(k) clearance K920708 for MULTILASE 2500 A, Substantially Equivalent on 1992-11-05. Applicant: Teknomed, Inc..

Clearance details

Applicant
Teknomed, Inc.
Product code
Code GEX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Danvers, MA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GEX

product code GEX
Death
33
Injury
3,045
Malfunction
12,903
Other
25
Total
16,006

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.