510(k) K080586

OLYMPUS XCHF TYPE B180Y1 by Olympus Medical Systems Corporation — Product Code FBN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 6, 2008
Date Received: March 3, 2008
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Choledochoscope And Accessories, Flexible/Rigid
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

to examine and perform procedures within the bile ducts. 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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Other clearances for product code FBN

K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, (January 20, 2026)
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K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV (March 7, 2025)
K241444 — Biliary Pancreaticobiliary Scope System (January 21, 2025)
K233752 — Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly I (May 2, 2024)
K231497 — Choledochoscope System (March 6, 2024)
K231105 — Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) (October 17, 2023)
K223741 — Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Fl (June 22, 2023)
K222261 — Flexible Video-Choledochoscope System (April 20, 2023)
K221784 — Single-use Video Pancreaticobiliary Scope, PB Digital Controller (February 16, 2023)