Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615480

FEI Number

3003793605

Entity Name

EVER CORP.

City/State/Country

Nasuhiobara City, TOCHIGI Tokyo, JP

Establishment Address

SAKITAMA 8-45, Nasuhiobara City, TOCHIGI Tokyo 325-0033, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EVER CORP. (Owner Number: 9028678)

Owner / Operator Contact Address

SAKITAMA 8-45, --, KUROISO CITY, TOCHIGI, JP-NOTA 325-0033, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012358

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2007-12-12
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2007-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

Maureen Young Business: ISPG, INC. Email: maureen.young@ispg.com Phone: (941) 8963999

Related Public Records

Same Entity

EVER CORP.

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
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615480. Last updated year: 2026. Please use registration number 9615480 when referencing this establishment in official correspondence.