Medical Device Manufacturer · US , Waltham , MA

Instylla, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2019

Recent clearances: Instylla Delivery Kit, Tembo Embolic System, TEMBO Embolic System

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Instylla, Inc. Cardiovascular ✕

6 devices

1-6 of 6

Cleared Jun 11, 2026

Verge™ Microcatheter

Cardiovascular · 28d

Cleared Dec 15, 2025

Tembo Embolic System

Cardiovascular · 24d

Cleared Dec 16, 2024

TEMBO Embolic System

Cardiovascular · 262d

Cleared Apr 15, 2021

Instylla Microcatheter 1.2

Cardiovascular · 29d

Cleared Apr 21, 2020

Instylla Microcatheter

Cardiovascular · 29d

Cleared Aug 13, 2019

Instylla Microcatheter

Cardiovascular · 46d