| Insufflation Retention Device (IRD) (11173-325-101) (K261587) | BPEndo, LLC | 2026-07-02 |
| Disposable Endoscopic Distal Attachments (K260423) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026-05-28 |
| Disposable Distal End Tape Hood (K252457) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2026-01-30 |
| ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) (K244029) | Endorobotics Co., Ltd. | 2025-09-24 |
| FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L (K243261) | Fujifilm Corporation | 2025-05-23 |
| Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) (K250432) | Olympus Medical Systems Corporation | 2025-05-15 |
| PENTAX Medical Video Colonoscope (EC38-i20cWL) (K242110) | Pentax of America, Inc. | 2025-01-03 |
| GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (K242325) | Actuated Medical, Inc. | 2024-10-04 |
| 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. | 2024-02-16 |
| GripTract-GI Endoscopic Tissue Manipulator (K231254) | Actuated Medical, Inc. | 2023-11-03 |
| Pure-Vu EVS System (K232922) | Motus GI Medical Technologies , Ltd. | 2023-10-20 |
| Ambu® aScope™ Colon; Ambu® aBox™ 2 (K230332) | Ambu A/S | 2023-09-15 |
| FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 (K223827) | Fujifilm Corporation | 2023-09-08 |
| Aer-O-Scope Colonoscope System (K230588) | Gi View , Ltd. | 2023-08-17 |
| DiLumen C1, EZ1 and Tool Mount (K221452) | Lumendi, LLC | 2023-02-10 |
| Insufflation Retention Device (K213773) | Bpendo, LLC | 2022-07-21 |
| G-EYE System (K220158) | Smart Medical Systems , Ltd. | 2022-04-11 |
| Balloon Dilatation Catheter (K213578) | Hangzhou AGS MedTech Co., Ltd. | 2022-04-06 |
| 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. | 2022-04-01 |
| Pure-Vu EVS System (K220007) | Motus GI Medical Technologies , Ltd. | 2022-02-10 |
| DiLumen C2 and Tool Mount (K211819) | Lumendi, LLC | 2021-10-22 |
| Pure Vu System (K210981) | Motus GI Medical Technologies , Ltd. | 2021-04-29 |
| DiLumen Endolumenal Interventional Platform (DiLumen) (K210851) | Lumendi, LLC | 2021-04-21 |
| G-EYE System (K202469) | Smart Medical Systems , Ltd. | 2020-10-26 |
| 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. | 2020-07-17 |
| G-EYE System (K192588) | Smart Medical Systems , Ltd. | 2020-04-15 |
| Endotics (K190669) | Era Endoscopy S.R.L. | 2020-01-03 |
| FUJIFILM Endoscope Model EC-760Z-V/L (K192664) | Fujifilm Corporation | 2019-11-20 |
| Pure Vu System (K191220) | Motus GI Medical Technologies , Ltd. | 2019-06-06 |
| FUJIFILM Endoscope Model EC-760S-V/L (K190649) | Fujifilm Corporation | 2019-05-07 |
| PENTAX Video Colonoscopes (EC Family) (K181084) | Pentax of America, Inc. | 2019-01-18 |
| DiLumen Endolumenal Interventional Platform (K182540) | Lumendi, LLC | 2018-10-30 |
| PENTAX Medical Video Colonoscope EC34-i10T Series (K180285) | Pentax Medical of America, Inc. | 2018-10-26 |
| Pure Vu System (K181437) | Motus GI Medical Technologies , Ltd. | 2018-06-21 |
| DiLumen C2; DiLumen Tool Mount (K173317) | Lumendi, LLC | 2018-04-17 |
| FUJIFILM Endoscope Models EC-600HL and EC-600LS (K180405) | Fujifilm Corporation | 2018-03-15 |
| Focus Cap (K171673) | Gce Medical Corporation | 2018-01-19 |
| invendoscopy E210 System (K173085) | Invendo Medical GmbH | 2018-01-08 |
| Pure-Vu System (K173392) | Motus GI Medical Technologies , Ltd. | 2017-12-12 |
| Medrobotics Flex Robotic System (K172036) | Medrobotics Corporation | 2017-08-03 |
| Flex Robotic System and Flex Colorectal Drive (K162330) | Medrobotics Corporation | 2017-05-04 |
| 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 (K163492) | United States Endoscopy Group, Inc. | 2017-01-06 |
| DiLumen Endolumenal Interventional Platform (K162428) | Lumendi, LLC | 2016-12-06 |
| Fujifilm Endoscope Models EC-600HL and EC-600LS (K162622) | Fujifilm Medical Systems U.S.A, Inc. | 2016-10-18 |
| Pure Vu (K160015) | Motus GI Medical Technologies , Ltd. | 2016-09-22 |
| invendoscopy E200 System (K161355) | Invendo Medical GmbH | 2016-08-25 |
| Aer-O-Scope Colonoscope System (K161791) | Gi View , Ltd. | 2016-08-11 |
| Third Eye Panoramic Auxiliary Endoscopy System - Resposable (K160356) | Avantis Medical Systems, Inc. | 2016-05-17 |
| Fujifilm Video Colonoscope Model EC-600WL V2 (K160196) | Fujifilm Medical Systems U.S.A, Inc. | 2016-02-23 |
| Balloon controller PB-30 (K153483) | Fujifilm Medical Systems U.S.A, Inc. | 2015-12-15 |
| FUJIFILM Endoscope Models EC-600HL and EC-600LS (K143732) | Fujifilm Medical Systems U.S.A, Inc. | 2015-07-06 |
| THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM (K140595) | Avantis Medical Systems, Inc. | 2014-11-17 |
| AER-O-SCOPE COLONOSCOPE SYSTEM (K141286) | Gi View , Ltd. | 2014-09-30 |
| FUSE COLONOSCOPY SYSTEM (K141598) | Endochoice, Inc. | 2014-09-30 |
| PENTAX VIDEO COLONOSCOPES (EC FAMILY) (K131855) | Pentax Medical Company | 2014-04-09 |
| FUSE 1C COLONOSCOPY SYSTEM (K132839) | Endochoice, Inc. | 2014-02-06 |
| FUJIFILM 600 SERIES ENDOSCOPES (K132210) | Fujifilm Medical Systems U.S.A, Inc. | 2014-01-10 |
| EVIS EXERA III VIDEO SYSTEM (K131780) | Olympus Medical Systems Corp. | 2013-08-29 |
| PEERSCOPE SYSTEM (K130718) | Peermedical , Ltd. | 2013-04-16 |
| INVENDO C25 COLONOSCOPY SYSTEM (K121582) | Invendo Medical Gbmh | 2012-12-20 |
| PEERSCOPE SYSTEM (K120289) | Peermedical | 2012-09-28 |
| FUJINON COLONOSCOPES (K112391) | Fujinon, Inc. | 2012-07-26 |
| CLEARPATH LOWER GI (K113050) | Easyglide , Ltd. | 2012-05-16 |
| V1 SYSTEM (K111756) | Olympus Medical Systems Corp. | 2012-03-20 |
| INVENDO C20 COLONOSCOPY SYSTEM (K100624) | Invendo Medical Gbmh | 2012-02-23 |
| EVIS EXERA III VIDEO SYSTEM (K112680) | Olympus Medical Systems Corporation | 2012-02-16 |
| EUS BALLOON (K111028) | United States Endoscopy Group, Inc. | 2011-11-01 |
| UPD-Y0003 (K103312) | Olympus Medical Systems Corporation | 2011-05-12 |
| NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE (K102616) | Smart Medical Systems , Ltd. | 2010-12-30 |
| COLONOSCOPE/SIGMOIDOSCOPE SHEATHES (K100966) | Sheathing Technologies, Inc. | 2010-08-03 |
| NAVIAID ICVI DEVICE (K101191) | Smart Medical Systems , Ltd. | 2010-07-27 |
| OLYMPUS CF TYPE Y0023-L, Y0023I (K101053) | Olympus Medical Systems Corporation | 2010-07-14 |
| PENTEX EC-3890LI (K093037) | Pentax Medical Company | 2009-12-28 |
| MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM (K093187) | Avantis Medical Systems, Inc. | 2009-11-05 |
| CLEARPATH (K091305) | Easyglide , Ltd. | 2009-10-23 |
| THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM (K091783) | Avantis Medical Systems, Inc. | 2009-07-07 |
| FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 (K090116) | Fujinon, Inc. | 2009-04-22 |
| THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM (K083180) | Avantis Medical Systems, Inc. | 2009-02-12 |
| PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL (K081004) | Stryker GI | 2008-05-02 |
| ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL (K080317) | Syntheon, LLC | 2008-04-29 |
| NEOGUIDE ENDOSCOPY SYSTEM (K070622) | Neoguide Systems, Inc. | 2007-08-14 |
| THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM (K070330) | Avantis Medical Systems, Inc. | 2007-04-24 |
| ENDOGUIDE (K063654) | Kms Medical, LLC | 2007-01-31 |
| KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM (K063585) | KARL STORZ Endoscopy-America, Inc. | 2007-01-31 |
| NAVIGATOR ENDOSCOPY SYSTEM (K052930) | Neoguide Systems, Inc. | 2006-01-31 |
| ZUTRON COLONOSCOPE STIFFENING DEVICE (K051068) | Zutron Medical | 2005-07-11 |
| GF-UE160-AL5 ULTRASOUND ENDOSCOPE (K051541) | Olympus America, Inc. | 2005-07-01 |
| EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 (K043487) | Aizu Olympus Co., Ltd. | 2005-01-28 |
| FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 (K041903) | Fujinon, Inc. | 2004-11-10 |
| COLONOSIGHT MODEL 510B (K032688) | Sightline Technologies , Ltd. | 2004-03-05 |
| INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 (K023259) | Helix Medical, Inc. | 2002-12-26 |
| ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D (K002749) | The Olympus Optical Co. | 2000-12-04 |
| EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I (K001241) | The Olympus Optical Co. | 2000-05-09 |
| GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS (K970372) | Precision Endoscopy of America, Inc. | 1997-03-11 |
| KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH) (K961570) | Pentax Precision Instrument Corp. | 1996-06-24 |
| EC-384OTL, VIDEO COLONSCOPE (K961563) | Pentax Precision Instrument Corp. | 1996-06-19 |
| EC-3800L, VIDEO COLONOSCOPE (K951574) | Pentax Precision Instrument Corp. | 1996-03-21 |
| EC-3800TL, VIDEO COLONOSCOPE (K951579) | Pentax Precision Instrument Corp. | 1996-03-21 |
| VS-200 VIDEO SIGMOIDOSCOPE (K954704) | Welch Allyn, Inc. | 1996-03-07 |
| FC-38TLH, FIBER COLONOSCOPE (K951575) | Pentax Precision Instrument Corp. | 1995-06-27 |