510(k) K093507

OLYMPUS CHF TYPE Y0003 by Olympus Medical Systems Corporation — Product Code FBN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 10, 2010
Date Received: November 13, 2009
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).

Other clearances by Olympus Medical Systems Corporation

K250993 — Single Use Cytology Brush V (BC-V600P-3010) (December 18, 2025)
K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (November 25, 2025)
K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp (October 21, 2025)
K252247 — Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use (October 16, 2025)
K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical (October 10, 2025)
K252150 — Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); (October 7, 2025)
K250187 — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (October 7, 2025)
K251859 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (October 3, 2025)
K251986 — AUXILIARY WATER TUBE MAJ-855 (September 26, 2025)
K251997 — Single-Use Biopsy Valve (MAJ-1555) (September 25, 2025)

Other clearances for product code FBN

K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, (January 20, 2026)
K251170 — Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tange (September 12, 2025)
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)