FDA Product Code FDF: Colonoscope And Accessories, Flexible/rigid
Colonoscopy is the gold standard for colorectal cancer screening and polyp removal. FDA product code FDF covers flexible and rigid colonoscopes and their accessories.
These long endoscopes allow gastroenterologists to visualize and perform procedures throughout the entire colon and terminal ileum. They are used for colorectal cancer screening, polyp removal, biopsy of inflammatory bowel disease, and treatment of gastrointestinal bleeding.
FDF devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Pentax Precision Instrument Corp., Motus GI Medical Technologies , Ltd. and Lumendi, LLC.
114
Total
114
Cleared
130d
Avg days
1976
Since
Growing category -
9 submissions in the last 2 years
vs 7 in the prior period
Consistent review times:
143d avg (recent)
FDA 510(k) Cleared Colonoscope And Accessories, Flexible/rigid Devices (Product Code FDF)
114 devices
Cleared
Aug 21, 2026
Solo Scope Colonoscope System
Gi View , Ltd.
Gastroenterology & Urology
147d
Cleared
Jul 02, 2026
Insufflation Retention Device (IRD) (11173-325-101)
Bpendo, LLC
Gastroenterology & Urology
50d
Cleared
May 28, 2026
Disposable Endoscopic Distal Attachments
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Gastroenterology & Urology
108d
Cleared
Jan 30, 2026
Disposable Distal End Tape Hood
Shanghai SeeGen Photoelectric Technology Co., Ltd.
Gastroenterology & Urology
178d
Cleared
Sep 24, 2025
ROBOPERA (ER-R-002)
Endorobotics Co., Ltd.
Gastroenterology & Urology
268d
Cleared
May 23, 2025
FUJIFILM Endoscope Model EC-860P/M
Fujifilm Corporation
Gastroenterology & Urology
220d
Cleared
May 15, 2025
Colonovideoscope (CF-EZ1500DL)
Olympus Medical Systems Corporation
Gastroenterology & Urology
90d
Cleared
Jan 03, 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
Pentax of America, Inc.
Gastroenterology & Urology
168d
Cleared
Oct 04, 2024
GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
Actuated Medical, Inc.
Gastroenterology & Urology
59d
Cleared
Feb 16, 2024
Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
Guangzhou Red Pine Medical Instrument Co., Ltd.
Gastroenterology & Urology
221d
Cleared
Nov 03, 2023
GripTract-GI Endoscopic Tissue Manipulator
Actuated Medical, Inc.
Gastroenterology & Urology
186d
Cleared
Oct 20, 2023
Pure-Vu EVS System
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology
31d
Cleared
Sep 15, 2023
Ambu® aScope™ Colon
Ambu A/S
Gastroenterology & Urology
220d
Cleared
Sep 08, 2023
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
Fujifilm Corporation
Gastroenterology & Urology
261d
Cleared
Aug 17, 2023
Aer-O-Scope Colonoscope System
Gi View , Ltd.
Gastroenterology & Urology
168d
Cleared
Feb 10, 2023
DiLumen C1, EZ1 and Tool Mount
Lumendi, LLC
Gastroenterology & Urology
268d
Cleared
Jul 21, 2022
Insufflation Retention Device
Bpendo, LLC
Gastroenterology & Urology
231d
Cleared
Apr 11, 2022
G-EYE System
Smart Medical Systems , Ltd.
Gastroenterology & Urology
82d
Cleared
Apr 06, 2022
Balloon Dilatation Catheter
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology
147d
Cleared
Apr 01, 2022
Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))
Saneso, Inc.
Gastroenterology & Urology
448d
Cleared
Feb 10, 2022
Pure-Vu EVS System
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology
37d
Cleared
Oct 22, 2021
DiLumen C2 and Tool Mount
Lumendi, LLC
Gastroenterology & Urology
133d
Cleared
Apr 29, 2021
Pure Vu System
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology
28d
Cleared
Apr 21, 2021
DiLumen Endolumenal Interventional Platform (DiLumen)
Lumendi, LLC
Gastroenterology & Urology
30d
About Product Code FDF - Regulatory Context
510(k) Submission Activity
114 total 510(k) submissions under product code FDF since 1976, with 114 receiving FDA clearance (average review time: 130 days).
Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 7 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - FDF Product Code
FDA review times for FDF submissions have been consistent, averaging 143 days recently vs 129 days historically.
FDF devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →