Data / Medical devices / United States / Instylla, Inc.

Instylla, Inc.: FDA-registered device maker in Bedford, MA, United States, 5 510(k) clearances and 1 PMA approval

Name: Instylla, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Instylla, Inc. is registered with the FDA (registration 3017208642) in Bedford, MA, United States. It lists 3 device types. The FDA files 5 510(k) clearances and 1 PMA approval under its listings, the newest dated December 22, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017208642
Address: 201 Burlington Rd, North Building, Bedford, MA, United States, 01730
Owner or operator: Instylla, Inc. (10077890)
Roles: Manufacturer
First device listed: October 5, 2020
Registered through: 2026
Brand names listed: Embrace Hydrogel Embolic System, Instylla Delivery Kit, Instylla Delivery Kit 1mL:1mL, Instylla Microcatheter, Instylla Microcatheter 1.2F

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Continuous Flush	KRA	2	Manufacturer	accessdata.fda.gov
Embolization Agent, Vascular	QVG	3	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 22, 2025	K253769	Instylla Delivery Kit	FMF	Substantially Equivalent	Instylla, Inc.	accessdata.fda.gov
February 10, 2022	K213632	Instylla Delivery Kit	FMF	Substantially Equivalent	Instylla, Inc.	accessdata.fda.gov
April 15, 2021	K210808	Instylla Microcatheter 1.2	KRA	Substantially Equivalent	Instylla, Inc.	accessdata.fda.gov
April 21, 2020	K200744	Instylla Microcatheter	KRA	Substantially Equivalent	Instylla, Inc.	accessdata.fda.gov
October 10, 2019	K191659	Instylla Delivery Kit	FMF	Substantially Equivalent	Instylla, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 5, 2025	P250003	Embrace(TM) Hydrogel Embolic System	QVG	10	October 23, 2026	accessdata.fda.gov

Compare with other makers

Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.