Instylla, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Instylla, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Instylla Delivery Kit, Tembo Embolic System, TEMBO Embolic System
10
Total
10
Cleared
0
Denied
Instylla, Inc. has 10 FDA 510(k) cleared medical devices. Based in Waltham, US.
Latest FDA clearance: Jun 2026. Active since 2019. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Instylla, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Instylla, Inc.
10 devices
Cleared
Jun 11, 2026
Verge™ Microcatheter
Cardiovascular
28d
Cleared
Dec 22, 2025
Instylla Delivery Kit
General Hospital
27d
Cleared
Dec 15, 2025
Tembo Embolic System
Cardiovascular
24d
Cleared
Dec 16, 2024
TEMBO Embolic System
Cardiovascular
262d
Cleared
Feb 10, 2022
Instylla Delivery Kit
General Hospital
85d
Cleared
Apr 15, 2021
Instylla Microcatheter 1.2
Cardiovascular
29d
Cleared
Jan 07, 2021
Instylla Delivery Kit
General Hospital
127d
Cleared
Apr 21, 2020
Instylla Microcatheter
Cardiovascular
29d
Cleared
Oct 10, 2019
Instylla Delivery Kit
General Hospital
111d
Cleared
Aug 13, 2019
Instylla Microcatheter
Cardiovascular
46d