Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1225984

FEI Number

3002516162

Entity Name

MYRIAD FIBER IMAGING TECHNOLOGIES, INC.

City/State/Country

DUDLEY, MA, US

Establishment Address

56 SOUTHBRIDGE RD, DUDLEY, MA 01571, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MYRIAD FIBER IMAGING TECHNOLOGIES, INC. (Owner Number: 9034673)

Owner / Operator Contact Address

56 SOUTHBRIDGE RD., --, Dudley, MA 01571, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AQUABEAM Robotic System Sinusleeve Vena MicroAngioscope System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PZP	Fluid Jet Removal System	General, Plastic Surgery	Class 2	876.4350	2025-07-25
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-01-29
ODF	Mini Endoscope, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-01-29
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2025-07-25
LYK	Angioscope	Gastroenterology, Urology	Class 2	876.1500	2025-11-25
LYK	Angioscope	Gastroenterology, Urology	Class 2	876.1500	2026-02-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-10-26

Official Correspondent

Kim Melanson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MYRIAD FIBER IMAGING TECHNOLOGIES, 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
K220587	Olympus Medical Systems Corp.	Evis Exera III Duodenovideoscope Olympus TJF-Q190V	2022-05-11
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K924554	Clarus Medical Systems, Inc.	CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE	1993-02-25
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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3013944123	Eurofins Infinity Laboratory Group Inc.	San Jose, CA, US
1222616	PRECISION OPTICS CORP.	GARDNER, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225984. Last updated year: 2026. Please use registration number 1225984 when referencing this establishment in official correspondence.