Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008040402

FEI Number

3008040402

Entity Name

Olympus Vietnam Co. Ltd.

City/State/Country

Dong Nai City, VN

Establishment Address

8 Street, Long Thanh Industrial Zone, An Phuoc Commune, Dong Nai City 810000, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OLYMPUS CORPORATION (Owner Number: 9067818)

Owner / Operator Contact Address

2951 ISHIKAWA-CHO, HACHIOJI-SHI, JP-13 192-8507, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251664

PMA Number

N/A

All Registered Proprietary Names

NM-400L-0525 NM-401L-0423 NM-400L-0621 NM-400U-0425 NM-400U-0623 NM-401L-0523 NM-401L-0623 NM-400L-0523 NM-401L-0525 NM-400L-0421 NM-401L-0425 NM-400U-0423 NM-400L-0623 NM-401L-0625 NM-400U-0525 NM-400U-0323 NM-400U-0523 NM-400L-0423 NM-400U-0625 NM-400L-0625 NM-400L-0425 NM-400Y-0423 MAJ-1414 FB-211D FB-241D FB-231D FB-221D KD-VC412Q-0215 KD-VC433Q-0720 KD-VC411Q-0320 KD-VC631Q-07203A KD-VC631Q-07303A KD-VC431Q-0720 KD-411Q-0730 KD-V411M-0720 KD-VC631Q-07301S KD-VC631Q-07303S KD-V411M-0330 KD-VC631Q-07201S KD-V411M-0725 KD-V411M-0320 KD-VC631Q-07203S KD-VC433Q-0730 KD-VC411Q-0330 KD-V431M-0720 KD-V411M-0730 KD-431Q-0720 KD-VC631Q-07201A KD-VC631Q-07301A KD-VC431Q-0730 KD-V431M-0730 NM-610L-0623 NM-610U-0423 NM-610L-0621 NM-610U-0323 NM-610U-0426 NM-610U-0425 NM-610L-0421 NM-610U-0523 NM-610L-0426 NM-610U-0623 NM-610L-0525 NM-610U-0326 NM-610L-0625 NM-610L-0423 NM-610L-0425 NM-610U-0525 NM-610L-0523 NM-610U-1826 NM-610L-0521 NM-610U-0625 SD-210U-15 SD-210U-25 SD-210U-10 FB-225U FB-215U FB-245U FB-210K FB-221K FB-242U FB-230K FB-210U FB-214U FB-235U FB-224U FB-222U FB-41ST-1 FB-211K FB-240K FB-234U FB-244U FB-50U-1 FB-240U FB-231K FB-241K FB-220K FB-230U FLEXIBLE BIOPSY FORCEP FB-212U FB-232U FB-220U FB-26N-1 SD-240U-15 SD-240U-10 SD-230U-20 MAJ-22 HX-400U-30 B-V243Q-A B-V433P-B B-V433P-A B-V443Q-B B-V233P-B B-V443Q-A B-V243Q-B B-V233P-A NA-201SX-4022 NA-201SX-4021

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2007-11-30
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-11-17
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2017-12-11
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2017-12-11
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2008-06-17
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2008-06-16
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-06-16
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2016-04-26
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2025-11-17
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2016-03-29
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2006-12-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-06-17
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2008-03-03
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-06-17
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2002-02-20
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2002-02-20
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2022-08-24
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2009-09-10
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2009-09-10
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2025-08-12

Official Correspondent

No official correspondent registered.

US Agent Details

Todd Brill Business: Gyrus ACMI, Inc. Email: todd.brill@olympus.com Phone: (508) 2077661

Related Public Records

Same Entity

OLYMPUS CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004450998	Gyrus ACMI, Inc.	Redmond, WA, US
3007389669	Algram Group Ltd	Plymouth Devon, GB
9611174	KEYMED (Medical & Industrial Equipment) Ltd	SOUTHEND-ON-SEA Essex, GB
3010590422	QUEST MEDICAL IMAGING	Wieringerwerf Noord-Holland, NL
3031983124	ODIN MEDICAL LIMITED	London London, City of, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
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-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4720

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3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3015136743	STERI-TECH CO.,LTD.	KAZO-SHI Saitama, JP
3014342096	KARL STORZ SE & CO KG	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008040402. Last updated year: 2026. Please use registration number 3008040402 when referencing this establishment in official correspondence.