FDA.reportPublic FDA data

Instylla, Inc.

Matched from indexed company URL: INSTYLLA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Instylla, Inc.5N2027-01-0115 Blue Sky Dr Burlington MA US 01803
30172086423017208642INSTYLLA, INC.1N2026-01-01201 Burlington Rd, North Building Bedford MA US 01730

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2792332006859213P250003Embrace(TM) Hydrogel Embolic SystemQVG2025-08-05
3532372006859213P250003Embrace(TM) Hydrogel Embolic SystemQVG2025-08-05
2792331142122005K253769Instylla Delivery KitFMF2025-12-22
3532371142122005K253769Instylla Delivery KitFMF2025-12-22
2792331275827878K213632Instylla Delivery KitFMF2022-02-10
3532371275827878K213632Instylla Delivery KitFMF2022-02-10
2792331237752890K210808Instylla Microcatheter 1.2KRA2021-04-15
3532371237752890K210808Instylla Microcatheter 1.2KRA2021-04-15
2792331990929665K200744Instylla MicrocatheterKRA2020-04-21
3532371990929665K200744Instylla MicrocatheterKRA2020-04-21
2792331087257177K191659Instylla Delivery KitFMF2019-10-10
3532371087257177K191659Instylla Delivery KitFMF2019-10-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMF62025-12-22
KRA42021-04-15

PMN#