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Instylla, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories4
Latest FDA decision2026-06-11
TypeNumberDevice NameCodeDateActions
510(k) K261610 Verge™ MicrocatheterKRA2026-06-11 View
PMA P250003 Embolization Agent, VascularQVG2026-04-02 View
510(k) K253769 Instylla Delivery KitFMF2025-12-22 View
510(k) K253677 Tembo Embolic SystemKRD2025-12-15 View
510(k) K240873 TEMBO Embolic SystemKRD2024-12-16 View
510(k) K213632 Instylla Delivery KitFMF2022-02-10 View
510(k) K210808 Instylla Microcatheter 1.2KRA2021-04-15 View
510(k) K202544 Instylla Delivery KitFMF2021-01-07 View
510(k) K200744 Instylla MicrocatheterKRA2020-04-21 View
510(k) K191659 Instylla Delivery KitFMF2019-10-10 View
510(k) K191731 Instylla MicrocatheterKRA2019-08-13 View

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