Product Code: FDF FDA class 2 21 CFR 876.1500

Colonoscope And Accessories, Flexible/Rigid

Gastroenterology, Urology

The Colonoscope and Accessories (Flexible/Rigid) (product code FDF) is an endoscopic instrument used to examine or perform procedures in the colon or rectum, including polypectomy, biopsy, and therapeutic interventions. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. For reusable flexible endoscopes of this type, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807).

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510(k)s

112

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FDF
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 112 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260423	Disposable Endoscopic Distal Attachments	May 28, 2026	Substantially Equivalent	Yangzhou Fartley Medical Instrument Technology Co., Ltd.
K252457	Disposable Distal End Tape Hood	Jan 30, 2026	Substantially Equivalent	Shanghai SeeGen Photoelectric Technology Co., Ltd.
K244029	ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)	Sep 24, 2025	Substantially Equivalent	Endorobotics Co., Ltd.
K243261	FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L	May 23, 2025	Substantially Equivalent	Fujifilm Corporation
K250432	Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)	May 15, 2025	Substantially Equivalent	Olympus Medical Systems Corporation
K242110	PENTAX Medical Video Colonoscope (EC38-i20cWL)	Jan 03, 2025	Substantially Equivalent	Pentax of America, Inc.
K242325	GripTract-GI Endoscopic Tissue Manipulator Lower GI Models	Oct 04, 2024	Substantially Equivalent	Actuated Medical, Inc.
K232043	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)	Feb 16, 2024	Substantially Equivalent	Guangzhou Red Pine Medical Instrument Co., Ltd.
K231254	GripTract-GI Endoscopic Tissue Manipulator	Nov 03, 2023	Substantially Equivalent	Actuated Medical, Inc.
K232922	Pure-Vu EVS System	Oct 20, 2023	Substantially Equivalent	Motus GI Medical Technologies , Ltd.
K230332	Ambu® aScope Colon; Ambu® aBox 2	Sep 15, 2023	Substantially Equivalent	Ambu A/S
K223827	FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01	Sep 08, 2023	Substantially Equivalent	Fujifilm Corporation
K230588	Aer-O-Scope Colonoscope System	Aug 17, 2023	Substantially Equivalent	Gi View , Ltd.
K221452	DiLumen C1, EZ1 and Tool Mount	Feb 10, 2023	Substantially Equivalent	Lumendi, LLC
K213773	Insufflation Retention Device	Jul 21, 2022	Substantially Equivalent	Bpendo, LLC
K220158	G-EYE System	Apr 11, 2022	Substantially Equivalent	Smart Medical Systems , Ltd.
K213578	Balloon Dilatation Catheter	Apr 06, 2022	Substantially Equivalent	Hangzhou AGS MedTech Co., Ltd.
K210052	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))	Apr 01, 2022	Substantially Equivalent	Saneso, Inc.
K220007	Pure-Vu EVS System	Feb 10, 2022	Substantially Equivalent	Motus GI Medical Technologies , Ltd.
K211819	DiLumen C2 and Tool Mount	Oct 22, 2021	Substantially Equivalent	Lumendi, LLC
K210981	Pure Vu System	Apr 29, 2021	Substantially Equivalent	Motus GI Medical Technologies , Ltd.
K210851	DiLumen Endolumenal Interventional Platform (DiLumen)	Apr 21, 2021	Substantially Equivalent	Lumendi, LLC
K202469	G-EYE System	Oct 26, 2020	Substantially Equivalent	Smart Medical Systems , Ltd.
K192793	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	Jul 17, 2020	Substantially Equivalent	Olympus Medical Systems Corp.
K192588	G-EYE System	Apr 15, 2020	Substantially Equivalent	Smart Medical Systems , Ltd.
K190669	Endotics	Jan 03, 2020	Substantially Equivalent	Era Endoscopy S.R.L.
K192664	FUJIFILM Endoscope Model EC-760Z-V/L	Nov 20, 2019	Substantially Equivalent	Fujifilm Corporation
K191220	Pure Vu System	Jun 06, 2019	Substantially Equivalent	Motus GI Medical Technologies , Ltd.
K190649	FUJIFILM Endoscope Model EC-760S-V/L	May 07, 2019	Substantially Equivalent	Fujifilm Corporation
K181084	PENTAX Video Colonoscopes (EC Family)	Jan 18, 2019	Substantially Equivalent	Pentax of America, Inc.
K182540	DiLumen Endolumenal Interventional Platform	Oct 30, 2018	Substantially Equivalent	Lumendi, LLC
K180285	PENTAX Medical Video Colonoscope EC34-i10T Series	Oct 26, 2018	Substantially Equivalent	Pentax Medical of America, Inc.
K181437	Pure Vu System	Jun 21, 2018	Substantially Equivalent	Motus GI Medical Technologies , Ltd.
K173317	DiLumen C2; DiLumen Tool Mount	Apr 17, 2018	Substantially Equivalent	Lumendi, LLC
K180405	FUJIFILM Endoscope Models EC-600HL and EC-600LS	Mar 15, 2018	Substantially Equivalent	Fujifilm Corporation
K171673	Focus Cap	Jan 19, 2018	Substantially Equivalent	Gce Medical Corporation
K173085	invendoscopy E210 System	Jan 08, 2018	Substantially Equivalent	Invendo Medical GmbH
K173392	Pure-Vu System	Dec 12, 2017	Substantially Equivalent	Motus GI Medical Technologies , Ltd.
K172036	Medrobotics Flex Robotic System	Aug 03, 2017	Substantially Equivalent	Medrobotics Corporation
K162330	Flex Robotic System and Flex Colorectal Drive	May 04, 2017	Substantially Equivalent	Medrobotics Corporation
K163492	Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear	Jan 06, 2017	Substantially Equivalent	United States Endoscopy Group, Inc.
K162428	DiLumen Endolumenal Interventional Platform	Dec 06, 2016	Substantially Equivalent	Lumendi, LLC
K162622	Fujifilm Endoscope Models EC-600HL and EC-600LS	Oct 18, 2016	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K160015	Pure Vu	Sep 22, 2016	Substantially Equivalent	Motus GI Medical Technologies , Ltd.
K161355	invendoscopy E200 System	Aug 25, 2016	Substantially Equivalent	Invendo Medical GmbH
K161791	Aer-O-Scope Colonoscope System	Aug 11, 2016	Substantially Equivalent	Gi View , Ltd.
K160356	Third Eye Panoramic Auxiliary Endoscopy System - Resposable	May 17, 2016	Substantially Equivalent	Avantis Medical Systems, Inc.
K160196	Fujifilm Video Colonoscope Model EC-600WL V2	Feb 23, 2016	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K153483	Balloon controller PB-30	Dec 15, 2015	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K143732	FUJIFILM Endoscope Models EC-600HL and EC-600LS	Jul 06, 2015	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K140595	THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM	Nov 17, 2014	Substantially Equivalent	Avantis Medical Systems, Inc.
K141598	FUSE COLONOSCOPY SYSTEM	Sep 30, 2014	Substantially Equivalent	Endochoice, Inc.
K141286	AER-O-SCOPE COLONOSCOPE SYSTEM	Sep 30, 2014	Substantially Equivalent	Gi View , Ltd.
K131855	PENTAX VIDEO COLONOSCOPES (EC FAMILY)	Apr 09, 2014	Substantially Equivalent	Pentax Medical Company
K132839	FUSE 1C COLONOSCOPY SYSTEM	Feb 06, 2014	Substantially Equivalent	Endochoice, Inc.
K132210	FUJIFILM 600 SERIES ENDOSCOPES	Jan 10, 2014	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K131780	EVIS EXERA III VIDEO SYSTEM	Aug 29, 2013	Substantially Equivalent	Olympus Medical Systems Corp.
K130718	PEERSCOPE SYSTEM	Apr 16, 2013	Substantially Equivalent	Peermedical , Ltd.
K121582	INVENDO C25 COLONOSCOPY SYSTEM	Dec 20, 2012	Substantially Equivalent	Invendo Medical Gbmh
K120289	PEERSCOPE SYSTEM	Sep 28, 2012	Substantially Equivalent	Peermedical
K112391	FUJINON COLONOSCOPES	Jul 26, 2012	Substantially Equivalent	Fujinon, Inc.
K113050	CLEARPATH LOWER GI	May 16, 2012	Substantially Equivalent	Easyglide , Ltd.
K111756	V1 SYSTEM	Mar 20, 2012	Substantially Equivalent	Olympus Medical Systems Corp.
K100624	INVENDO C20 COLONOSCOPY SYSTEM	Feb 23, 2012	Substantially Equivalent	Invendo Medical Gbmh
K112680	EVIS EXERA III VIDEO SYSTEM	Feb 16, 2012	Substantially Equivalent	Olympus Medical Systems Corporation
K111028	EUS BALLOON	Nov 01, 2011	Substantially Equivalent	United States Endoscopy Group, Inc.
K103312	UPD-Y0003	May 12, 2011	Substantially Equivalent	Olympus Medical Systems Corporation
K102616	NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE	Dec 30, 2010	Substantially Equivalent	Smart Medical Systems , Ltd.
K100966	COLONOSCOPE/SIGMOIDOSCOPE SHEATHES	Aug 03, 2010	Substantially Equivalent	Sheathing Technologies, Inc.
K101191	NAVIAID ICVI DEVICE	Jul 27, 2010	Substantially Equivalent	Smart Medical Systems , Ltd.
K101053	OLYMPUS CF TYPE Y0023-L, Y0023I	Jul 14, 2010	Substantially Equivalent	Olympus Medical Systems Corporation
K093037	PENTEX EC-3890LI	Dec 28, 2009	Substantially Equivalent	Pentax Medical Company
K093187	MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM	Nov 05, 2009	Substantially Equivalent	Avantis Medical Systems, Inc.
K091305	CLEARPATH	Oct 23, 2009	Substantially Equivalent	Easyglide , Ltd.
K091783	THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM	Jul 07, 2009	Substantially Equivalent	Avantis Medical Systems, Inc.
K090116	FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15	Apr 22, 2009	Substantially Equivalent	Fujinon, Inc.
K083180	THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM	Feb 12, 2009	Substantially Equivalent	Avantis Medical Systems, Inc.
K081004	PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL	May 02, 2008	Substantially Equivalent	Stryker GI
K080317	ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL	Apr 29, 2008	Substantially Equivalent	Syntheon, LLC
K070622	NEOGUIDE ENDOSCOPY SYSTEM	Aug 14, 2007	Substantially Equivalent	Neoguide Systems, Inc.
K070330	THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM	Apr 24, 2007	Substantially Equivalent	Avantis Medical Systems, Inc.
K063654	ENDOGUIDE	Jan 31, 2007	Substantially Equivalent	Kms Medical, LLC
K063585	KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM	Jan 31, 2007	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K052930	NAVIGATOR ENDOSCOPY SYSTEM	Jan 31, 2006	Substantially Equivalent	Neoguide Systems, Inc.
K051068	ZUTRON COLONOSCOPE STIFFENING DEVICE	Jul 11, 2005	Substantially Equivalent	Zutron Medical
K051541	GF-UE160-AL5 ULTRASOUND ENDOSCOPE	Jul 01, 2005	Substantially Equivalent	Olympus America, Inc.
K043487	EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1	Jan 28, 2005	Substantially Equivalent	Aizu Olympus Co., Ltd.
K041903	FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5	Nov 10, 2004	Substantially Equivalent	Fujinon, Inc.
K032688	COLONOSIGHT MODEL 510B	Mar 05, 2004	Substantially Equivalent	Sightline Technologies , Ltd.
K023259	INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200	Dec 26, 2002	Substantially Equivalent	Helix Medical, Inc.
K002749	ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D	Dec 04, 2000	Substantially Equivalent	The Olympus Optical Co.
K001241	EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I	May 09, 2000	Substantially Equivalent	The Olympus Optical Co.
K970372	GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS	Mar 11, 1997	Substantially Equivalent	Precision Endoscopy of America, Inc.
K961570	KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)	Jun 24, 1996	Substantially Equivalent	Pentax Precision Instrument Corp.
K961563	EC-384OTL, VIDEO COLONSCOPE	Jun 19, 1996	Substantially Equivalent	Pentax Precision Instrument Corp.
K951579	EC-3800TL, VIDEO COLONOSCOPE	Mar 21, 1996	Substantially Equivalent	Pentax Precision Instrument Corp.
K951574	EC-3800L, VIDEO COLONOSCOPE	Mar 21, 1996	Substantially Equivalent	Pentax Precision Instrument Corp.
K954704	VS-200 VIDEO SIGMOIDOSCOPE	Mar 07, 1996	Substantially Equivalent	Welch Allyn, Inc.
K951580	FC-38LH, FIBER COLONOSCCOPE	Jun 27, 1995	Substantially Equivalent	Pentax Precision Instrument Corp.
K951578	FC-38LX, FIBER COLONOSCOPE	Jun 27, 1995	Substantially Equivalent	Pentax Precision Instrument Corp.
K951575	FC-38TLH, FIBER COLONOSCOPE	Jun 27, 1995	Substantially Equivalent	Pentax Precision Instrument Corp.
K943895	VISION SYSTEM COLONSCOPE	Feb 03, 1995	Substantially Equivalent	Vision-Sciences, Inc.
K901610	SULLIVAN VARIABLE STIFFNESS CABLE	Jun 29, 1990	Substantially Equivalent	Wilson-Cook Medical, Inc.
K884857	COLONOSCOPE GUIDING TUBE DEVICE	Mar 17, 1989	Substantially Equivalent	Mill-Rose Laboratory
K822846	PENTAX FC-38LA & FC-38SA COLONOFIBER	Oct 22, 1982	Substantially Equivalent	Pentax Precision Instrument Corp.
K810682	PENTAX COLONOSCOPE MODEL FC-34LA	Apr 03, 1981	Substantially Equivalent	Pentax Precision Instrument Corp.
K810791	PENTAX COLONOSCOPE MODEL FC-34 MA	Mar 31, 1981	Substantially Equivalent	Pentax Precision Instrument Corp.
K810654	STOPPERLESS HOT/COLD RUBBER WATER BOTTLE	Mar 27, 1981	Substantially Equivalent	First Industries, Inc.
K801223	PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A	Jun 09, 1980	Substantially Equivalent	Pentax Precision Instrument Corp.
K792179	AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE	Dec 06, 1979	Substantially Equivalent	American Optical Corp.
K790338	COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER	Apr 04, 1979	Substantially Equivalent	American Optical Corp.
K760452	COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92)	Aug 30, 1976	Substantially Equivalent	American Cystocope Makers, Inc.