Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611481

FEI Number

3002807220

Entity Name

HAKKO CO., LTD.

City/State/Country

CHIKUMA-SHI Nagano, JP

Establishment Address

1490 O-aza Isobe, CHIKUMA-SHI Nagano 389-0806, JP

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HAKKO CO., LTD. (Owner Number: 8030409)

Owner / Operator Contact Address

1490 O-Aza Isobe, Chikuma-shi, JP-20 3890806, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stimuplex (DIG,RC, A) Hakko Spinal Needle Echostim Facet Tip Sonopsy Needle Tuohy Epidural Needle Soft Tissue Retractor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BXN	Stimulator, Nerve, Battery-Powered	Anesthesiology	Class 2	868.2775	2012-12-14
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2007-11-13
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2012-02-10
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2007-11-13
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2007-11-13
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2025-01-08

Official Correspondent

No official correspondent registered.

US Agent Details

Derek Wessman Business: Derek Wessman/Mr. Email: usagent@jataki.com Phone: (801) 6569278

Related Public Records

Same Entity

HAKKO CO., LTD.

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
K860126	Burron Medical Products, Inc.	STIMUPLEX, NERVE STIMULATOR	1986-02-28
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

Similar Registrations

Registration Number	Establishment Name	Location
9610825	B. BRAUN MELSUNGEN AG	MELSUNGEN Hesse, DE
3004748541	Salter Labs	El Paso, TX, US
2022648	Anesthesia Associates, Inc.	SAN MARCOS, CA, US
3001650535	Suzhou Meccan Import and Export Corp.	Suzhou Jiangsu, CN
2183613	NORTECH SYSTEMS, INC.	Milaca, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611481. Last updated year: 2026. Please use registration number 9611481 when referencing this establishment in official correspondence.