FDF · Class II · 21 CFR 876.1500

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 Lumendi, LLC, Fujifilm Corporation and Motus GI Medical Technologies , Ltd..

112
Total
112
Cleared
131d
Avg days
1976
Since
Stable submission activity - 7 submissions in the last 2 years
Review times increasing: avg 156d recently vs 129d historically

FDA 510(k) Cleared Colonoscope And Accessories, Flexible/rigid Devices (Product Code FDF)

112 devices
1–24 of 112
Cleared May 28, 2026
Disposable Endoscopic Distal Attachments
K260423
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Gastroenterology & Urology · 108d
Cleared Jan 30, 2026
Disposable Distal End Tape Hood
K252457
Shanghai SeeGen Photoelectric Technology Co., Ltd.
Gastroenterology & Urology · 178d
Cleared Sep 24, 2025
ROBOPERA (ER-R-002)
K244029
Endorobotics Co., Ltd.
Gastroenterology & Urology · 268d
Cleared May 23, 2025
FUJIFILM Endoscope Model EC-860P/M
K243261
Fujifilm Corporation
Gastroenterology & Urology · 220d
Cleared May 15, 2025
Colonovideoscope (CF-EZ1500DL)
K250432
Olympus Medical Systems Corporation
Gastroenterology & Urology · 90d
Cleared Jan 03, 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
K242110
Pentax of America, Inc.
Gastroenterology & Urology · 168d
Cleared Oct 04, 2024
GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
K242325
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)
K232043
Guangzhou Red Pine Medical Instrument Co., Ltd.
Gastroenterology & Urology · 221d
Cleared Nov 03, 2023
GripTract-GI Endoscopic Tissue Manipulator
K231254
Actuated Medical, Inc.
Gastroenterology & Urology · 186d
Cleared Oct 20, 2023
Pure-Vu EVS System
K232922
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology · 31d
Cleared Sep 15, 2023
Ambu® aScope™ Colon
K230332
Ambu A/S
Gastroenterology & Urology · 220d
Cleared Sep 08, 2023
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
K223827
Fujifilm Corporation
Gastroenterology & Urology · 261d
Cleared Aug 17, 2023
Aer-O-Scope Colonoscope System
K230588
Gi View , Ltd.
Gastroenterology & Urology · 168d
Cleared Feb 10, 2023
DiLumen C1, EZ1 and Tool Mount
K221452
Lumendi, LLC
Gastroenterology & Urology · 268d
Cleared Jul 21, 2022
Insufflation Retention Device
K213773
Bpendo, LLC
Gastroenterology & Urology · 231d
Cleared Apr 11, 2022
G-EYE System
K220158
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 82d
Cleared Apr 06, 2022
Balloon Dilatation Catheter
K213578
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))
K210052
Saneso, Inc.
Gastroenterology & Urology · 448d
Cleared Feb 10, 2022
Pure-Vu EVS System
K220007
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology · 37d
Cleared Oct 22, 2021
DiLumen C2 and Tool Mount
K211819
Lumendi, LLC
Gastroenterology & Urology · 133d
Cleared Apr 29, 2021
Pure Vu System
K210981
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology · 28d
Cleared Apr 21, 2021
DiLumen Endolumenal Interventional Platform (DiLumen)
K210851
Lumendi, LLC
Gastroenterology & Urology · 30d
Cleared Oct 26, 2020
G-EYE System
K202469
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 60d
Cleared Jul 17, 2020
Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
K192793
Olympus Medical Systems Corp.
Gastroenterology & Urology · 291d

About Product Code FDF - Regulatory Context

510(k) Submission Activity

112 total 510(k) submissions under product code FDF since 1976, with 112 receiving FDA clearance (average review time: 131 days).

Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.

FDA 510(k) Review Time - FDF Product Code

Recent submissions under FDF have taken an average of 156 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.

FDF devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →