Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002806337

FEI Number

3002806337

Entity Name

Akita Sumitomo Bakelite Co., Ltd.

City/State/Country

Akita, JP

Establishment Address

27-4, Aza Nakajimashita, Souzen-machi, Tsuchizakiminato, Akita 011-8510, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SB-KAWASUMI LABORATORIES, INC. (Owner Number: 8031539)

Owner / Operator Contact Address

3-25-4 Tonomachi, Kawasaki-ku, Kawasaki-shi, JP-14 210-8602, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SB Knife Jr2 SB Knife Jr2 - Long SB Knife Jr Type SB Knife Standard Type SB Knife Short Type SB Knife Jr Type - Long SwiftNINJA Microcatheter Embryo Grid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2025-12-08
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2021-12-16
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2021-12-20
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6160	2026-04-13

Official Correspondent

Kenichi Inamura

US Agent Details

TAKAHITO ISHIKAWA Business: SUMITOMO PLASTICS AMERICA, INC. Email: t_ishikawa@sumibe.co.jp Phone: (408) 3355883

Related Public Records

Same Entity

SB-KAWASUMI LABORATORIES, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010141954	Sumitomo Bakelite (Dongguan) Co., Ltd.	Dongguan Guangdong, CN
1055927	KAWASUMI LABORATORIES AMERICA, INC.	Tampa, FL, US
9615908	KAWASUMI LABORATORIES (THAILAND) CO., LTD.	CHOK CHAI Nakhon Ratchasima, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17
K792141	Pharmaseal Div., Baxter Healthcare Corp.	CONTINUOUS FLUSH DEVICE	1979-12-05
K924661	Baxter Healthcare Corp	SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER	1993-04-08

Similar Registrations

Registration Number	Establishment Name	Location
3013526170	Jiangsu Vedkang Medical Science and Technology Co.,Ltd.	Changzhou Jiangsu, CN
1000121056	Boston Scientific Corporation	Coventry, RI, US
3002807310	Synergy Health Sterilisation UK Ltd	Berkshire Reading, GB
1320894	CONMED CORPORATION	Utica, NY, US
3014769442	Aomori Olympus Co., Ltd. Hirosaki Site	Hirosaki-shi Aomori, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002806337. Last updated year: 2026. Please use registration number 3002806337 when referencing this establishment in official correspondence.