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Instylla, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253769Instylla Delivery KitDecember 22, 2025
K253677Tembo Embolic SystemDecember 15, 2025
K240873TEMBO Embolic SystemDecember 16, 2024
K213632Instylla Delivery KitFebruary 10, 2022
K210808Instylla Microcatheter 1.2April 15, 2021
K202544Instylla Delivery KitJanuary 7, 2021
K200744Instylla MicrocatheterApril 21, 2020
K191659Instylla Delivery KitOctober 10, 2019
K191731Instylla MicrocatheterAugust 13, 2019