Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1226424

FEI Number

3003018854

Entity Name

HYDROCISION, INC.

City/State/Country

BILLERICA, MA, US

Establishment Address

267 Boston Road, Suite 28, BILLERICA, MA 01862, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

HYDROCISION, INC. (Owner Number: 9041017)

Owner / Operator Contact Address

267 Boston Road, Suite 28, North Billerica, MA 01862, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HydroCision SpineJet System HydroCision ArthroJet System with Cautory Turbo Burr and Currette, (51300, 51310) HydroCision Console

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2020-04-24
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2000-04-10
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2003-07-17

Official Correspondent

Mark Lewis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HYDROCISION, 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
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

Similar Registrations

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1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
3014615697	AMNOTEC INTERNATIONAL MEDICAL GMBH	Neuhausen ob Eck Baden-Wurttemberg, DE
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1226424. Last updated year: 2026. Please use registration number 1226424 when referencing this establishment in official correspondence.