ClearanceBrief
Panels › Gastroenterology, Urology › Product code FDF · Class 2

Colonoscope And Accessories, Flexible/Rigid

Regulation 876.1500

5510(k)s in 12 months (115 all time)
0recalls in 12 months (25 all time)
25recalls that name a 510(k)
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Top companies in FDF

Company510(k)sRecalls
Pentax Precision Instrument Corp.110
Aizu Olympus Co., Ltd.16
Motus GI Medical Technologies , Ltd.70
Olympus Medical Systems Corp.70
Olympus Corporation of the Americas07
Pentax of America, Inc.25
Avantis Medical Systems, Inc.60
Lumendi, LLC60
Fujifilm Corporation50
Fujifilm Medical Systems U.S.A, Inc.50
Decided510(k)Device and applicantCode
Sep 3, 2026K260503Triton 1 System
Neptune Medical, Inc.
FDF
Aug 21, 2026K261015Solo Scope Colonoscope System
Gi View, Ltd., IL
FDF
Jul 2, 2026K261587Insufflation Retention Device (IRD) (11173-325-101)
BPEndo, LLC
FDF
May 28, 2026K260423Disposable Endoscopic Distal Attachments
Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN
FDF
Jan 30, 2026K252457Disposable Distal End Tape Hood
Shanghai SeeGen Photoelectric Technology Co., Ltd., CN
FDF
Sep 24, 2025K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
Endorobotics Co., Ltd., KR
FDF
May 23, 2025K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
Fujifilm Corporation, JP
FDF
May 15, 2025K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)
Olympus Medical Systems Corporation, JP
FDF
Jan 3, 2025K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)
Pentax of America, Inc.
FDF
Oct 4, 2024K242325GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
Actuated Medical, Inc.
FDF
Feb 16, 2024K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastros
Guangzhou Red Pine Medical Instrument Co., Ltd., CN
FDF
Nov 3, 2023K231254GripTract-GI Endoscopic Tissue Manipulator
Actuated Medical, Inc.
FDF
Oct 20, 2023K232922Pure-Vu EVS System
Motus GI Medical Technologies , Ltd., IL
FDF
Sep 15, 2023K230332Ambu® aScope™ Colon; Ambu® aBox™ 2
Ambu A/S, DK
FDF
Sep 8, 2023K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
Fujifilm Corporation, JP
FDF
Aug 17, 2023K230588Aer-O-Scope Colonoscope System
Gi View , Ltd., IL
FDF
Feb 10, 2023K221452DiLumen C1, EZ1 and Tool Mount
Lumendi, LLC
FDF
Jul 21, 2022K213773Insufflation Retention Device
Bpendo, LLC
FDF
Apr 11, 2022K220158G-EYE System
Smart Medical Systems , Ltd., IL
FDF
Apr 6, 2022K213578Balloon Dilatation Catheter
Hangzhou AGS MedTech Co., Ltd., CN
FDF
Apr 1, 2022K210052Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso
Saneso, Inc.
FDF
Feb 10, 2022K220007Pure-Vu EVS System
Motus GI Medical Technologies , Ltd., IL
FDF
Oct 22, 2021K211819DiLumen C2 and Tool Mount
Lumendi, LLC
FDF
Apr 29, 2021K210981Pure Vu System
Motus GI Medical Technologies , Ltd., IL
FDF
Apr 21, 2021K210851DiLumen Endolumenal Interventional Platform (DiLumen)
Lumendi, LLC
FDF
Oct 26, 2020K202469G-EYE System
Smart Medical Systems , Ltd., IL
FDF
Jul 17, 2020K192793Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III C
Olympus Medical Systems Corp., JP
FDF
Apr 15, 2020K192588G-EYE System
Smart Medical Systems , Ltd., IL
FDF
Jan 3, 2020K190669Endotics
Era Endoscopy S.R.L., IT
FDF
Nov 20, 2019K192664FUJIFILM Endoscope Model EC-760Z-V/L
Fujifilm Corporation, JP
FDF
Jun 6, 2019K191220Pure Vu System
Motus GI Medical Technologies , Ltd., IL
FDF
May 7, 2019K190649FUJIFILM Endoscope Model EC-760S-V/L
Fujifilm Corporation, JP
FDF
Jan 18, 2019K181084PENTAX Video Colonoscopes (EC Family)
Pentax of America, Inc.
FDF
Oct 30, 2018K182540DiLumen Endolumenal Interventional Platform
Lumendi, LLC
FDF
Oct 26, 2018K180285PENTAX Medical Video Colonoscope EC34-i10T Series
Pentax Medical of America, Inc.
FDF
Jun 21, 2018K181437Pure Vu System
Motus GI Medical Technologies , Ltd., IL
FDF
Apr 17, 2018K173317DiLumen C2; DiLumen Tool Mount
Lumendi, LLC
FDF
Mar 15, 2018K180405FUJIFILM Endoscope Models EC-600HL and EC-600LS
Fujifilm Corporation, JP
FDF
Jan 19, 2018K171673Focus Cap
Gce Medical Corporation
FDF
Jan 8, 2018K173085invendoscopy E210 System
Invendo Medical GmbH, DE
FDF
Dec 12, 2017K173392Pure-Vu System
Motus GI Medical Technologies , Ltd., IL
FDF
Aug 3, 2017K172036Medrobotics Flex Robotic System
Medrobotics Corporation
FDF
May 4, 2017K162330Flex Robotic System and Flex Colorectal Drive
Medrobotics Corporation
FDF
Jan 6, 2017K163492Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS lat
United States Endoscopy Group, Inc.
FDF
Dec 6, 2016K162428DiLumen Endolumenal Interventional Platform
Lumendi, LLC
FDF
Oct 18, 2016K162622Fujifilm Endoscope Models EC-600HL and EC-600LS
Fujifilm Medical Systems U.S.A, Inc.
FDF
Sep 22, 2016K160015Pure Vu
Motus GI Medical Technologies , Ltd., IL
FDF
Aug 25, 2016K161355invendoscopy E200 System
Invendo Medical GmbH, DE
FDF
Aug 11, 2016K161791Aer-O-Scope Colonoscope System
Gi View , Ltd., IL
FDF
May 17, 2016K160356Third Eye Panoramic Auxiliary Endoscopy System - Resposable
Avantis Medical Systems, Inc.
FDF

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