Cleared Traditional

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)

K241532 · Shanghai SeeGen Photoelectric Technology Co., Ltd. · Gastroenterology & Urology

Oct 2024

Decision

145d

Days

Class 2

Risk

About This 510(k) Submission

K241532 is an FDA 510(k) clearance for the Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100), a Endoscopic Video Imaging System/component, Gastroenterology-urology (Class II — Special Controls, product code FET), submitted by Shanghai SeeGen Photoelectric Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 22, 2024, 145 days after receiving the submission on May 30, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K241532 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2024
Decision Date	October 22, 2024
Days to Decision	145 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FET — Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.