FDA 510(k) Premarket Notification K233321: Double Balloon Endoscope EN-840T, Over-tube TS-1214C

Submission Details & Decision

Normalized public record details for 510(k) notification K233321.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K233321

Applicant / Sponsor

FUJIFILM Healthcare Americas Corporation

Device Name

Double Balloon Endoscope EN-840T, Over-tube TS-1214C

Product Code

FDA

Decision Date

2024-06-13

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Traditional

Third Party Flag

Date Received

2023-09-29

Related Establishments / Registrations

FUJIFILM Healthcare Americas Corporation Registration: 1000513161 View Registration
Primo Medical Group, INC Registration: 1222928 View Registration
FUJI SYSTEMS CORPORATION, Shirakawa Plant Registration: 3000308637 View Registration
SHIRAKAWA OLYMPUS CO., LTD. Registration: 3002808148 View Registration
FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office Registration: 3003775006 View Registration
Dalian Create Medical Products Co., LTD. Registration: 3004052101 View Registration
Spirus Medical, LLC Registration: 3005814162 View Registration
FUJIFILM Healthcare Manufacturing Corporation Sano Office Registration: 3006161756 View Registration
IAN JAMIESON PTY LTD Registration: 3008386005 View Registration
JAPAN GAS COMPANY LIMITED Registration: 3010188783 View Registration
Gyrus ACMI, Inc. Registration: 3011050570 View Registration
FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant Registration: 3014766734 View Registration
STERI-TECH CO.,LTD. Registration: 3015136743 View Registration
TOCHIGICHIZUKA PLANT Registration: 3017140456 View Registration
ASPERO MEDICAL, INC. Registration: 3029545567 View Registration
NZ BIOMED LIMITED Registration: 3042172882 View Registration
FUJIFILM Corporation Medical Systems Research & Development Center Kaisei Registration: 3042225166 View Registration
OLYMPUS MEDICAL SYSTEMS CORP. Registration: 8010047 View Registration
AIZU OLYMPUS CO., LTD. Registration: 9610595 View Registration

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