Bistool is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Bistool - FDA 510(k) Cleared Devices
Recent clearances: SOFTXIL
1
Total
1
Cleared
0
Denied
Bistool has 1 FDA 510(k) cleared medical devices. Based in Seoul, KR.
Historical record: 1 cleared submissions from 2018 to 2018. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Bistool Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by LK Consulting Group USA, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Bistool
1 devices