Medical Device Manufacturer · US , Boca Raton , FL

Assut Europe S.P.A. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2002

Recent clearances: Assut Filbloc Permanent Sutures, ASSUFIL

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Assut Europe S.P.A. General & Plastic Surgery ✕

2 devices

1-2 of 2

Cleared Aug 29, 2017

Assut Filbloc Permanent Sutures

General & Plastic Surgery · 145d

Cleared Nov 19, 2002

General & Plastic Surgery · 174d

Data Source

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

Last updated: Sep 14, 2026