FDA Product Code FGB: Ureteroscope And Accessories, Flexible/rigid
Ureteroscopy has revolutionized the management of upper urinary tract conditions. FDA product code FGB covers flexible and rigid ureteroscopes and their accessories.
These endoscopic instruments allow urologists to directly access and visualize the ureter and renal pelvis for the diagnosis and treatment of kidney stones, ureteral strictures, and upper tract tumors — without open surgery.
FGB devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Shanghai AnQing Medical Instrument Co., Ltd., KARL STORZ Endoscopy-America, Inc. and Boston Scientific Corporation.
114
Total
114
Cleared
131d
Avg days
1981
Since
Stable submission activity - 25 submissions in the last 2 years
Review times increasing: avg
149d
recently vs 126d historically
FDA 510(k) Cleared Ureteroscope And Accessories, Flexible/rigid Devices (Product Code FGB)
114 devices
Cleared
Apr 09, 2026
Single Use Digital Flexible Ureteroscope (7.5F)
Anhui Happiness Workshop Instruments Co., Ltd.
Gastroenterology & Urology
206d
Cleared
Mar 06, 2026
CVAC Image Processor
Calyxo, Inc.
Gastroenterology & Urology
60d
Cleared
Dec 16, 2025
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3)
Guangzhou Red Pine Medical Instrument Co., Ltd.
Gastroenterology & Urology
174d
Cleared
Dec 16, 2025
Single-use Digital Flexible Ureteroscope (GY-UR9.3)
Zhejiang Geyi Medical Instrument Co., Ltd.
Gastroenterology & Urology
132d
Cleared
Nov 18, 2025
Miniature Telescope for Urology (27033AA)
Karl Storz SE & CO. KG
Gastroenterology & Urology
49d
Cleared
Oct 31, 2025
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
Shenzhen Sanping Image Technology Co., Ltd.
Gastroenterology & Urology
218d
Cleared
Oct 03, 2025
Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
Shanghai AnQing Medical Instrument Co., Ltd.
Gastroenterology & Urology
30d
Cleared
Sep 24, 2025
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000)
Boston Scientific Corporation
Gastroenterology & Urology
28d
Cleared
Aug 26, 2025
Medical Video Endoscope [Standard Deflection] (URS3005)
Seplou (Zhuhai) Co., Ltd.
Gastroenterology & Urology
228d
Cleared
Jun 06, 2025
KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
Karl Storz SE & CO. KG
Gastroenterology & Urology
203d
Cleared
May 28, 2025
Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US)
Opcom Medical, Inc.
Gastroenterology & Urology
261d
Cleared
May 06, 2025
Single-use Flexible Ureteroscope
Hunan Vathin Medical Instrument Co., Ltd.
Gastroenterology & Urology
53d
Cleared
May 02, 2025
F88 URE-SD/RD Flexible Ureteroscope
Sg Endoscopy Pte, Ltd.
Gastroenterology & Urology
135d
Cleared
Apr 28, 2025
LumiRex Ureteroscope
Contra Healthcare Solutions, LLC
Gastroenterology & Urology
164d
Cleared
Apr 11, 2025
Flexible Ureterorenoscope (US27F-12-EU
Shanghai AnQing Medical Instrument Co., Ltd.
Gastroenterology & Urology
116d
Cleared
Mar 27, 2025
Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P
Scivita Medical Technology Co., Ltd.
Gastroenterology & Urology
115d
Cleared
Feb 11, 2025
Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
Dongguan Zsr Biomedical Technology Company Limited
Gastroenterology & Urology
134d
Cleared
Jan 29, 2025
Digital Video Processor
Hunan Vathin Medical Instrument Co., Ltd.
Gastroenterology & Urology
121d
Cleared
Jan 22, 2025
Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)
Hunan Endoso Life Technology Co., Ltd.
Gastroenterology & Urology
203d
Cleared
Oct 04, 2024
Single use flexible ureteroscope (UR-D1)
Shenzhen Besdata Technology Co., Ltd.
Gastroenterology & Urology
268d
Cleared
Oct 04, 2024
Video Ureteroscope System
Hunan Vathin Medical Instrument Co., Ltd.
Gastroenterology & Urology
136d
Cleared
Sep 05, 2024
URUS System (DMG-SU100/URUS)
Dyne Medical Group, Inc.
Gastroenterology & Urology
224d
Cleared
Aug 16, 2024
Avicenna Roboflex
Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi
General & Plastic Surgery
273d
Cleared
Aug 16, 2024
Ambu® aScope™ 5 Uretero (Standard Deflection)
Ambu A/S
Gastroenterology & Urology
29d
About Product Code FGB - Regulatory Context
510(k) Submission Activity
114 total 510(k) submissions under product code FGB since 1981, with 114 receiving FDA clearance (average review time: 131 days).
Submission volume has remained relatively stable over the observed period, with 25 submissions in the last 24 months.
FDA 510(k) Review Time - FGB Product Code
Recent submissions under FGB have taken an average of 149 days to reach a decision - up from 126 days historically. Manufacturers should account for longer review timelines in current project planning.
FGB devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →