Medical Device Manufacturer · US , Burlington , MA

Fasstech - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1993

Recent clearances: INSIGHT DISCOVERY, CWAS 1000, INSIGHT MILLENNIUM III

View 9 510(k) Devices ↓

Total

Cleared

Denied

Fasstech has 9 FDA 510(k) cleared medical devices. Based in Burlington, US.

Historical record: 9 cleared submissions from 1993 to 2007. Primary specialty: Neurology.

Browse the FDA 510(k) cleared devices submitted by Fasstech Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Entela, Inc. and Intertek Testing Services.

Fasstech is one of 24569 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Fasstech

9 devices

1-9 of 9

INSIGHT MILLENNIUM III

K023209 · IKN

Neurology · 379d

Cleared Sep 20, 2001

INSIGHT MILLENNIUM PLUS

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 10, 2026

Fasstech - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Fasstech

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