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510(k) K221952

Endoscope Model EG-580UT and Endoscope Model EG-580UR by Fujifilm Corporation — Product Code ODG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2022
Date Received
July 5, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Ultrasound System, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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  • K212852 — Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic (December 6, 2021)
  • K203166 — PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultraso (December 30, 2020)
  • K200090 — PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper (July 23, 2020)