Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit— 510(k) K200848

Substantially Equivalent

Micron Medical Corporation

FDA 510(k) clearance K200848 for Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit, Substantially Equivalent on 2020-08-14. Applicant: Micron Medical Corporation.

Clearance details

Applicant: Micron Medical Corporation
Product code: Code GZF
Advisory panel: Neurology
Date received: 2020-03-31
Decision date: 2020-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GZF

product code GZF

Death: 10
Injury: 2,410
Other: 1
Total: 2,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.