INSTYLLA, INC.

FDA Device Registration & Listing · Bedford, MA, US · Registration 3017208642

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017208642
FEI Number
3017208642
Entity Name
INSTYLLA, INC.
City/State/Country
Bedford, MA, US
Establishment Address
201 Burlington Rd, North Building, Bedford, MA 01730, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Instylla, Inc. (Owner Number: 10077890)
Owner / Operator Contact Address
201 Burlington Rd, North Building, Bedford, MA 01730, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K191659
PMA Number
N/A

All Registered Proprietary Names

Instylla Delivery Kit 1mL:1mL Embrace Hydrogel Embolic System Instylla Microcatheter Instylla Microcatheter 1.2F Instylla Delivery Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMF Syringe, Piston General Hospital Class 2 880.5860 2026-03-04
QVG Embolization Agent, Vascular Unknown Class 3 N/A 2025-11-17
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2020-10-05
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2021-08-31
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-10-05

Official Correspondent

Amita Shah

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Instylla, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12
K792141 Pharmaseal Div., Baxter Healthcare Corp. CONTINUOUS FLUSH DEVICE 1979-12-05
K924661 Baxter Healthcare Corp SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER 1993-04-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017208642. Last updated year: 2026. Please use registration number 3017208642 when referencing this establishment in official correspondence.
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