FDF · Colonoscope And Accessories, Flexible/Rigid
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | FDF |
|---|---|
| Device Name | Colonoscope And Accessories, Flexible/Rigid |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Classification Rationale
(1) Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. (2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
Cleared Devices (111)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252457 | Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co., Ltd. | Jan 30, 2026 | SESE |
| K244029 | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | Endorobotics Co., Ltd. | Sep 24, 2025 | SESE |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L | Fujifilm Corporation | May 23, 2025 | SESE |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) | Olympus Medical Systems Corporation | May 15, 2025 | SESE |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | Pentax of America, Inc. | Jan 3, 2025 | SESE |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | Actuated Medical, Inc. | Oct 4, 2024 | SESE |
| 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) | Guangzhou Red Pine Medical Instrument Co., Ltd. | Feb 16, 2024 | SESE |
| K231254 | GripTract-GI Endoscopic Tissue Manipulator | Actuated Medical, Inc. | Nov 3, 2023 | SESE |
| K232922 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | Oct 20, 2023 | SESE |
| K230332 | Ambu® aScope Colon; Ambu® aBox 2 | Ambu A/S | Sep 15, 2023 | SESE |
| K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | Sep 8, 2023 | SESE |
| K230588 | Aer-O-Scope Colonoscope System | Gi View , Ltd. | Aug 17, 2023 | SESE |
| K221452 | DiLumen C1, EZ1 and Tool Mount | Lumendi, LLC | Feb 10, 2023 | SESE |
| K213773 | Insufflation Retention Device | Bpendo, LLC | Jul 21, 2022 | SESE |
| K220158 | G-EYE System | Smart Medical Systems , Ltd. | Apr 11, 2022 | SESE |
| K213578 | Balloon Dilatation Catheter | Hangzhou AGS MedTech Co., Ltd. | Apr 6, 2022 | SESE |
| 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)) | Saneso, Inc. | Apr 1, 2022 | SESE |
| K220007 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | Feb 10, 2022 | SESE |
| K211819 | DiLumen C2 and Tool Mount | Lumendi, LLC | Oct 22, 2021 | SESE |
| K210981 | Pure Vu System | Motus GI Medical Technologies , Ltd. | Apr 29, 2021 | SESE |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi, LLC | Apr 21, 2021 | SESE |
| K202469 | G-EYE System | Smart Medical Systems , Ltd. | Oct 26, 2020 | SESE |
| 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 | Olympus Medical Systems Corp. | Jul 17, 2020 | SESE |
| K192588 | G-EYE System | Smart Medical Systems , Ltd. | Apr 15, 2020 | SESE |
| K190669 | Endotics | Era Endoscopy S.R.L. | Jan 3, 2020 | SESE |
| K192664 | FUJIFILM Endoscope Model EC-760Z-V/L | Fujifilm Corporation | Nov 20, 2019 | SESE |
| K191220 | Pure Vu System | Motus GI Medical Technologies , Ltd. | Jun 6, 2019 | SESE |
| K190649 | FUJIFILM Endoscope Model EC-760S-V/L | Fujifilm Corporation | May 7, 2019 | SESE |
| K181084 | PENTAX Video Colonoscopes (EC Family) | Pentax of America, Inc. | Jan 18, 2019 | SESE |
| K182540 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | Oct 30, 2018 | SESE |
| K180285 | PENTAX Medical Video Colonoscope EC34-i10T Series | Pentax Medical of America, Inc. | Oct 26, 2018 | SESE |
| K181437 | Pure Vu System | Motus GI Medical Technologies , Ltd. | Jun 21, 2018 | SESE |
| K173317 | DiLumen C2; DiLumen Tool Mount | Lumendi, LLC | Apr 17, 2018 | SESE |
| K180405 | FUJIFILM Endoscope Models EC-600HL and EC-600LS | Fujifilm Corporation | Mar 15, 2018 | SESE |
| K171673 | Focus Cap | Gce Medical Corporation | Jan 19, 2018 | SESE |
| K173085 | invendoscopy E210 System | Invendo Medical GmbH | Jan 8, 2018 | SESE |
| K173392 | Pure-Vu System | Motus GI Medical Technologies , Ltd. | Dec 12, 2017 | SESE |
| K172036 | Medrobotics Flex Robotic System | Medrobotics Corporation | Aug 3, 2017 | SESE |
| K162330 | Flex Robotic System and Flex Colorectal Drive | Medrobotics Corporation | May 4, 2017 | SESE |
| 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 | United States Endoscopy Group, Inc. | Jan 6, 2017 | SESE |
| K162428 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | Dec 6, 2016 | SESE |
| K162622 | Fujifilm Endoscope Models EC-600HL and EC-600LS | Fujifilm Medical Systems U.S.A, Inc. | Oct 18, 2016 | SESE |
| K160015 | Pure Vu | Motus GI Medical Technologies , Ltd. | Sep 22, 2016 | SESE |
| K161355 | invendoscopy E200 System | Invendo Medical GmbH | Aug 25, 2016 | SESE |
| K161791 | Aer-O-Scope Colonoscope System | Gi View , Ltd. | Aug 11, 2016 | SESE |
| K160356 | Third Eye Panoramic Auxiliary Endoscopy System - Resposable | Avantis Medical Systems, Inc. | May 17, 2016 | SESE |
| K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 | Fujifilm Medical Systems U.S.A, Inc. | Feb 23, 2016 | SESE |
| K153483 | Balloon controller PB-30 | Fujifilm Medical Systems U.S.A, Inc. | Dec 15, 2015 | SESE |
| K143732 | FUJIFILM Endoscope Models EC-600HL and EC-600LS | Fujifilm Medical Systems U.S.A, Inc. | Jul 6, 2015 | SESE |
| K140595 | THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM | Avantis Medical Systems, Inc. | Nov 17, 2014 | SESE |
| K141598 | FUSE COLONOSCOPY SYSTEM | Endochoice, Inc. | Sep 30, 2014 | SESE |
| K141286 | AER-O-SCOPE COLONOSCOPE SYSTEM | Gi View , Ltd. | Sep 30, 2014 | SESE |
| K131855 | PENTAX VIDEO COLONOSCOPES (EC FAMILY) | Pentax Medical Company | Apr 9, 2014 | SESE |
| K132839 | FUSE 1C COLONOSCOPY SYSTEM | Endochoice, Inc. | Feb 6, 2014 | SESE |
| K132210 | FUJIFILM 600 SERIES ENDOSCOPES | Fujifilm Medical Systems U.S.A, Inc. | Jan 10, 2014 | SESE |
| K131780 | EVIS EXERA III VIDEO SYSTEM | Olympus Medical Systems Corp. | Aug 29, 2013 | SESE |
| K130718 | PEERSCOPE SYSTEM | Peermedical , Ltd. | Apr 16, 2013 | SESE |
| K121582 | INVENDO C25 COLONOSCOPY SYSTEM | Invendo Medical Gbmh | Dec 20, 2012 | SESE |
| K120289 | PEERSCOPE SYSTEM | Peermedical | Sep 28, 2012 | SESE |
| K112391 | FUJINON COLONOSCOPES | Fujinon, Inc. | Jul 26, 2012 | SESE |
| K113050 | CLEARPATH LOWER GI | Easyglide , Ltd. | May 16, 2012 | SESE |
| K111756 | V1 SYSTEM | Olympus Medical Systems Corp. | Mar 20, 2012 | SESE |
| K100624 | INVENDO C20 COLONOSCOPY SYSTEM | Invendo Medical Gbmh | Feb 23, 2012 | SESE |
| K112680 | EVIS EXERA III VIDEO SYSTEM | Olympus Medical Systems Corporation | Feb 16, 2012 | SESE |
| K111028 | EUS BALLOON | United States Endoscopy Group, Inc. | Nov 1, 2011 | SESE |
| K103312 | UPD-Y0003 | Olympus Medical Systems Corporation | May 12, 2011 | SESE |
| K102616 | NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE | Smart Medical Systems , Ltd. | Dec 30, 2010 | SESE |
| K100966 | COLONOSCOPE/SIGMOIDOSCOPE SHEATHES | Sheathing Technologies, Inc. | Aug 3, 2010 | SESE |
| K101191 | NAVIAID ICVI DEVICE | Smart Medical Systems , Ltd. | Jul 27, 2010 | SESE |
| K101053 | OLYMPUS CF TYPE Y0023-L, Y0023I | Olympus Medical Systems Corporation | Jul 14, 2010 | SESE |
| K093037 | PENTEX EC-3890LI | Pentax Medical Company | Dec 28, 2009 | SESE |
| K093187 | MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | Avantis Medical Systems, Inc. | Nov 5, 2009 | SESE |
| K091305 | CLEARPATH | Easyglide , Ltd. | Oct 23, 2009 | SESE |
| K091783 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM | Avantis Medical Systems, Inc. | Jul 7, 2009 | SESE |
| K090116 | FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 | Fujinon, Inc. | Apr 22, 2009 | SESE |
| K083180 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | Avantis Medical Systems, Inc. | Feb 12, 2009 | SESE |
| K081004 | PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL | Stryker GI | May 2, 2008 | SESE |
| K080317 | ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL | Syntheon, LLC | Apr 29, 2008 | SESE |
| K070622 | NEOGUIDE ENDOSCOPY SYSTEM | Neoguide Systems, Inc. | Aug 14, 2007 | SESE |
| K070330 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | Avantis Medical Systems, Inc. | Apr 24, 2007 | SESE |
| K063654 | ENDOGUIDE | Kms Medical, LLC | Jan 31, 2007 | SESE |
| K063585 | KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM | KARL STORZ Endoscopy-America, Inc. | Jan 31, 2007 | SESE |
| K052930 | NAVIGATOR ENDOSCOPY SYSTEM | Neoguide Systems, Inc. | Jan 31, 2006 | SESE |
| K051068 | ZUTRON COLONOSCOPE STIFFENING DEVICE | Zutron Medical | Jul 11, 2005 | SESE |
| K051541 | GF-UE160-AL5 ULTRASOUND ENDOSCOPE | Olympus America, Inc. | Jul 1, 2005 | SESE |
| K043487 | EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 | Aizu Olympus Co., Ltd. | Jan 28, 2005 | SESE |
| K041903 | FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 | Fujinon, Inc. | Nov 10, 2004 | SESE |
| K032688 | COLONOSIGHT MODEL 510B | Sightline Technologies , Ltd. | Mar 5, 2004 | SESE |
| K023259 | INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 | Helix Medical, Inc. | Dec 26, 2002 | SESE |
| K002749 | ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D | The Olympus Optical Co. | Dec 4, 2000 | SESE |
| K001241 | EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I | The Olympus Optical Co. | May 9, 2000 | SESE |
| K970372 | GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS | Precision Endoscopy of America, Inc. | Mar 11, 1997 | SESE |
| K961570 | KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH) | Pentax Precision Instrument Corp. | Jun 24, 1996 | SESE |
| K961563 | EC-384OTL, VIDEO COLONSCOPE | Pentax Precision Instrument Corp. | Jun 19, 1996 | SESE |
| K951579 | EC-3800TL, VIDEO COLONOSCOPE | Pentax Precision Instrument Corp. | Mar 21, 1996 | SESE |
| K951574 | EC-3800L, VIDEO COLONOSCOPE | Pentax Precision Instrument Corp. | Mar 21, 1996 | SESE |
| K954704 | VS-200 VIDEO SIGMOIDOSCOPE | Welch Allyn, Inc. | Mar 7, 1996 | SESE |
| K951580 | FC-38LH, FIBER COLONOSCCOPE | Pentax Precision Instrument Corp. | Jun 27, 1995 | SESE |
| K951578 | FC-38LX, FIBER COLONOSCOPE | Pentax Precision Instrument Corp. | Jun 27, 1995 | SESE |
| K951575 | FC-38TLH, FIBER COLONOSCOPE | Pentax Precision Instrument Corp. | Jun 27, 1995 | SESE |
| K943895 | VISION SYSTEM COLONSCOPE | Vision-Sciences, Inc. | Feb 3, 1995 | SESE |
| K901610 | SULLIVAN VARIABLE STIFFNESS CABLE | Wilson-Cook Medical, Inc. | Jun 29, 1990 | SESE |
| K884857 | COLONOSCOPE GUIDING TUBE DEVICE | Mill-Rose Laboratory | Mar 17, 1989 | SESE |
| K822846 | PENTAX FC-38LA & FC-38SA COLONOFIBER | Pentax Precision Instrument Corp. | Oct 22, 1982 | SESE |
| K810682 | PENTAX COLONOSCOPE MODEL FC-34LA | Pentax Precision Instrument Corp. | Apr 3, 1981 | SESE |
| K810791 | PENTAX COLONOSCOPE MODEL FC-34 MA | Pentax Precision Instrument Corp. | Mar 31, 1981 | SESE |
| K810654 | STOPPERLESS HOT/COLD RUBBER WATER BOTTLE | First Industries, Inc. | Mar 27, 1981 | SESE |
| K801223 | PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A | Pentax Precision Instrument Corp. | Jun 9, 1980 | SESE |
| K792179 | AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE | American Optical Corp. | Dec 6, 1979 | SESE |
| K790338 | COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER | American Optical Corp. | Apr 4, 1979 | SESE |
| K760452 | COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92) | American Cystocope Makers, Inc. | Aug 30, 1976 | SESE |
Top Applicants
- Pentax Precision Instrument Corp. — 11 clearances
- Motus GI Medical Technologies , Ltd. — 7 clearances
- Lumendi, LLC — 6 clearances
- Avantis Medical Systems, Inc. — 6 clearances
- Smart Medical Systems , Ltd. — 5 clearances
