Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011581884

FEI Number

3011581884

Entity Name

ALCYONE THERAPEUTICS, INC.

City/State/Country

Lowell, MA, US

Establishment Address

116 John Street, Suite 300, Lowell, MA 01852, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Alcyone Therapeutics, Inc. (Owner Number: 10049170)

Owner / Operator Contact Address

225 Binney Street, Cambridge, MA 02142, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ThecaFlex DRx System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKK	Pump, Infusion, Implanted, Programmable	Unknown	Class 3	N/A	2026-06-10

Official Correspondent

Glen Smythe

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alcyone Therapeutics, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2007	Medtronic Neuromodulation	3	Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

Similar Registrations

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3003174284	NextPhase Medical Devices, LLC	MANSFIELD, MA, US
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1422634	MEDLINE INDUSTRIES, LP (Northpoint Services)	Waukegan, IL, US
3004209178	MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS	Juncos, PR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011581884. Last updated year: 2026. Please use registration number 3011581884 when referencing this establishment in official correspondence.