Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015218018

FEI Number

3015218018

Entity Name

FUJIISEIKO CO., LTD.

City/State/Country

Kurate-machi Fukuoka, JP

Establishment Address

1057-1, Muroki,, Kurate-machi Fukuoka 807-1307, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Fujiiseiko Co., Ltd. (Owner Number: 10082901)

Owner / Operator Contact Address

1057-1, Muroki,, Kurate-machi, JP-40 807-1307, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iAccess Precision Blade iAccess Trabecular Trephine

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-11-06
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2021-10-12

Official Correspondent

No official correspondent registered.

US Agent Details

Tora Hoppe Business: Advanced Micro Precision, LLC. Email: thoppe@am-precision.com Phone: (562) 3291654

Related Public Records

Same Entity

Fujiiseiko 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
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

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8010851	BERNHARD FREY	TUTTLINGEN Baden-Wurttemberg, DE
2029275	Sterigenics U.S., LLC	Corona, CA, US
9681540	ULTRA SURGICAL (PVT.) LTD	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015218018. Last updated year: 2026. Please use registration number 3015218018 when referencing this establishment in official correspondence.