MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200— 510(k) K082565

Substantially Equivalent

Microsurgeon, Inc.

FDA 510(k) clearance K082565 for MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200, Substantially Equivalent on 2009-02-12. Applicant: Microsurgeon, Inc..

Clearance details

Applicant
Microsurgeon, Inc.
Product code
Code NEY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Montrose, CO, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code NEY

product code NEY
Death
24
Injury
388
Malfunction
462
Other
1
Total
875

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.