Medical Device Manufacturer · US , Malborough , MA

BTL Industries, Inc. - FDA 510(k) Cleared Devices

44 submissions · 44 cleared · Since 2010

Recent clearances: BTL-299-F, BTL-699, BTL-899TT

View 44 510(k) Devices ↓ Official Website
44
Total
44
Cleared
0
Denied

FDA 510(k) Regulatory Record - BTL Industries, Inc. Gastroenterology & Urology ✕

4 devices
1-4 of 4
Cleared Sep 23, 2026
BTL-299-F
K262353 · KPI
Gastroenterology & Urology · 75d
Cleared Feb 10, 2025
BTL-398
K241516 · KPI
Gastroenterology & Urology · 257d
Cleared Nov 14, 2018
HPM-6000UF
K181497 · KPI
Gastroenterology & Urology · 160d
Cleared Dec 13, 2016
HPM-6000U
K162010 · KPI
Gastroenterology & Urology · 146d
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