Cleared Traditional

Choledochoscope System

K231497 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · Gastroenterology & Urology

Mar 2024

Decision

287d

Days

Class 2

Risk

About This 510(k) Submission

K231497 is an FDA 510(k) clearance for the Choledochoscope System, a Choledochoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FBN), submitted by Shenzhen HugeMed Medical Technical Development Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 6, 2024, 287 days after receiving the submission on May 24, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K231497 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2023
Decision Date	March 06, 2024
Days to Decision	287 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FBN — Choledochoscope And Accessories, Flexible/rigid
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	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).