FDA Product Code
FDA Product Code FDF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 115 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260503 | Triton 1 System | Neptune Medical, Inc. | 2026-09-03 | Traditional | PDF ↗ |
| K261015 | Solo Scope Colonoscope System | Gi View, Ltd. | 2026-08-21 | Traditional | PDF ↗ |
| K261587 | Insufflation Retention Device (IRD) (11173-325-101) | BPEndo, LLC | 2026-07-02 | Special | PDF ↗ |
| K260423 | Disposable Endoscopic Distal Attachments | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026-05-28 | Traditional | PDF ↗ |
| K252457 | Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2026-01-30 | Traditional | PDF ↗ |
| K244029 | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | Endorobotics Co., Ltd. | 2025-09-24 | Traditional | PDF ↗ |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L | Fujifilm Corporation | 2025-05-23 | Traditional | PDF ↗ |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) | Olympus Medical Systems Corporation | 2025-05-15 | Traditional | PDF ↗ |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | Pentax of America, Inc. | 2025-01-03 | Traditional | PDF ↗ |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | Actuated Medical, Inc. | 2024-10-04 | Traditional | PDF ↗ |
| 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. | 2024-02-16 | Traditional | PDF ↗ |
| K231254 | GripTract-GI Endoscopic Tissue Manipulator | Actuated Medical, Inc. | 2023-11-03 | Traditional | PDF ↗ |
| K232922 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | 2023-10-20 | Special | PDF ↗ |
| K230332 | Ambu® aScope Colon; Ambu® aBox 2 | Ambu A/S | 2023-09-15 | Traditional | PDF ↗ |
| K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | 2023-09-08 | Traditional | PDF ↗ |
| K230588 | Aer-O-Scope Colonoscope System | Gi View , Ltd. | 2023-08-17 | Traditional | PDF ↗ |
| K221452 | DiLumen C1, EZ1 and Tool Mount | Lumendi, LLC | 2023-02-10 | Traditional | PDF ↗ |
| K213773 | Insufflation Retention Device | Bpendo, LLC | 2022-07-21 | Traditional | PDF ↗ |
| K220158 | G-EYE System | Smart Medical Systems , Ltd. | 2022-04-11 | Traditional | PDF ↗ |
| K213578 | Balloon Dilatation Catheter | Hangzhou AGS MedTech Co., Ltd. | 2022-04-06 | Traditional | PDF ↗ |
| 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. | 2022-04-01 | Traditional | PDF ↗ |
| K220007 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | 2022-02-10 | Special | PDF ↗ |
| K211819 | DiLumen C2 and Tool Mount | Lumendi, LLC | 2021-10-22 | Traditional | PDF ↗ |
| K210981 | Pure Vu System | Motus GI Medical Technologies , Ltd. | 2021-04-29 | Special | PDF ↗ |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi, LLC | 2021-04-21 | Special | PDF ↗ |
| K202469 | G-EYE System | Smart Medical Systems , Ltd. | 2020-10-26 | Traditional | PDF ↗ |
| 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. | 2020-07-17 | Traditional | PDF ↗ |
| K192588 | G-EYE System | Smart Medical Systems , Ltd. | 2020-04-15 | Traditional | PDF ↗ |
| K190669 | Endotics | Era Endoscopy S.R.L. | 2020-01-03 | Traditional | PDF ↗ |
| K192664 | FUJIFILM Endoscope Model EC-760Z-V/L | Fujifilm Corporation | 2019-11-20 | Traditional | PDF ↗ |
| K191220 | Pure Vu System | Motus GI Medical Technologies , Ltd. | 2019-06-06 | Special | PDF ↗ |
| K190649 | FUJIFILM Endoscope Model EC-760S-V/L | Fujifilm Corporation | 2019-05-07 | Special | PDF ↗ |
| K181084 | PENTAX Video Colonoscopes (EC Family) | Pentax of America, Inc. | 2019-01-18 | Traditional | PDF ↗ |
| K182540 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2018-10-30 | Traditional | PDF ↗ |
| K180285 | PENTAX Medical Video Colonoscope EC34-i10T Series | Pentax Medical of America, Inc. | 2018-10-26 | Traditional | PDF ↗ |
| K181437 | Pure Vu System | Motus GI Medical Technologies , Ltd. | 2018-06-21 | Special | PDF ↗ |
| K173317 | DiLumen C2; DiLumen Tool Mount | Lumendi, LLC | 2018-04-17 | Traditional | PDF ↗ |
| K180405 | FUJIFILM Endoscope Models EC-600HL and EC-600LS | Fujifilm Corporation | 2018-03-15 | Special | PDF ↗ |
| K171673 | Focus Cap | Gce Medical Corporation | 2018-01-19 | Traditional | PDF ↗ |
| K173085 | invendoscopy E210 System | Invendo Medical GmbH | 2018-01-08 | Traditional | PDF ↗ |
| K173392 | Pure-Vu System | Motus GI Medical Technologies , Ltd. | 2017-12-12 | Special | PDF ↗ |
| K172036 | Medrobotics Flex Robotic System | Medrobotics Corporation | 2017-08-03 | Special | PDF ↗ |
| K162330 | Flex Robotic System and Flex Colorectal Drive | Medrobotics Corporation | 2017-05-04 | Traditional | PDF ↗ |
| 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. | 2017-01-06 | Special | PDF ↗ |
| K162428 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2016-12-06 | Traditional | PDF ↗ |
| K162622 | Fujifilm Endoscope Models EC-600HL and EC-600LS | Fujifilm Medical Systems U.S.A, Inc. | 2016-10-18 | Special | PDF ↗ |
| K160015 | Pure Vu | Motus GI Medical Technologies , Ltd. | 2016-09-22 | Traditional | PDF ↗ |
| K161355 | invendoscopy E200 System | Invendo Medical GmbH | 2016-08-25 | Traditional | PDF ↗ |
| K161791 | Aer-O-Scope Colonoscope System | Gi View , Ltd. | 2016-08-11 | Traditional | PDF ↗ |
| K160356 | Third Eye Panoramic Auxiliary Endoscopy System - Resposable | Avantis Medical Systems, Inc. | 2016-05-17 | Traditional | PDF ↗ |
| K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 | Fujifilm Medical Systems U.S.A, Inc. | 2016-02-23 | Special | PDF ↗ |
| K153483 | Balloon controller PB-30 | Fujifilm Medical Systems U.S.A, Inc. | 2015-12-15 | Special | PDF ↗ |
| K143732 | FUJIFILM Endoscope Models EC-600HL and EC-600LS | Fujifilm Medical Systems U.S.A, Inc. | 2015-07-06 | Traditional | PDF ↗ |
| K140595 | THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM | Avantis Medical Systems, Inc. | 2014-11-17 | Traditional | PDF ↗ |
| K141286 | AER-O-SCOPE COLONOSCOPE SYSTEM | Gi View , Ltd. | 2014-09-30 | Traditional | PDF ↗ |
| K141598 | FUSE COLONOSCOPY SYSTEM | Endochoice, Inc. | 2014-09-30 | Special | PDF ↗ |
| K131855 | PENTAX VIDEO COLONOSCOPES (EC FAMILY) | Pentax Medical Company | 2014-04-09 | Traditional | PDF ↗ |
| K132839 | FUSE 1C COLONOSCOPY SYSTEM | Endochoice, Inc. | 2014-02-06 | Traditional | PDF ↗ |
| K132210 | FUJIFILM 600 SERIES ENDOSCOPES | Fujifilm Medical Systems U.S.A, Inc. | 2014-01-10 | Traditional | PDF ↗ |
| K131780 | EVIS EXERA III VIDEO SYSTEM | Olympus Medical Systems Corp. | 2013-08-29 | Special | PDF ↗ |
| K130718 | PEERSCOPE SYSTEM | Peermedical , Ltd. | 2013-04-16 | Special | PDF ↗ |
| K121582 | INVENDO C25 COLONOSCOPY SYSTEM | Invendo Medical Gbmh | 2012-12-20 | Special | PDF ↗ |
| K120289 | PEERSCOPE SYSTEM | Peermedical | 2012-09-28 | Traditional | PDF ↗ |
| K112391 | FUJINON COLONOSCOPES | Fujinon, Inc. | 2012-07-26 | Special | PDF ↗ |
| K113050 | CLEARPATH LOWER GI | Easyglide , Ltd. | 2012-05-16 | Special | PDF ↗ |
| K111756 | V1 SYSTEM | Olympus Medical Systems Corp. | 2012-03-20 | Traditional | PDF ↗ |
| K100624 | INVENDO C20 COLONOSCOPY SYSTEM | Invendo Medical Gbmh | 2012-02-23 | Traditional | PDF ↗ |
| K112680 | EVIS EXERA III VIDEO SYSTEM | Olympus Medical Systems Corporation | 2012-02-16 | Traditional | PDF ↗ |
| K111028 | EUS BALLOON | United States Endoscopy Group, Inc. | 2011-11-01 | Traditional | PDF ↗ |
| K103312 | UPD-Y0003 | Olympus Medical Systems Corporation | 2011-05-12 | Traditional | PDF ↗ |
| K102616 | NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE | Smart Medical Systems , Ltd. | 2010-12-30 | Traditional | PDF ↗ |
| K100966 | COLONOSCOPE/SIGMOIDOSCOPE SHEATHES | Sheathing Technologies, Inc. | 2010-08-03 | Traditional | PDF ↗ |
| K101191 | NAVIAID ICVI DEVICE | Smart Medical Systems , Ltd. | 2010-07-27 | Traditional | PDF ↗ |
| K101053 | OLYMPUS CF TYPE Y0023-L, Y0023I | Olympus Medical Systems Corporation | 2010-07-14 | Traditional | PDF ↗ |
| K093037 | PENTEX EC-3890LI | Pentax Medical Company | 2009-12-28 | Traditional | PDF ↗ |
| K093187 | MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | Avantis Medical Systems, Inc. | 2009-11-05 | Special | PDF ↗ |
| K091305 | CLEARPATH | Easyglide , Ltd. | 2009-10-23 | Traditional | PDF ↗ |
| K091783 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM | Avantis Medical Systems, Inc. | 2009-07-07 | Special | PDF ↗ |
| K090116 | FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 | Fujinon, Inc. | 2009-04-22 | Traditional | PDF ↗ |
| K083180 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | Avantis Medical Systems, Inc. | 2009-02-12 | Traditional | PDF ↗ |
| K081004 | PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL | Stryker GI | 2008-05-02 | Special | PDF ↗ |
| 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 | 2008-04-29 | Traditional | PDF ↗ |
| K070622 | NEOGUIDE ENDOSCOPY SYSTEM | Neoguide Systems, Inc. | 2007-08-14 | Traditional | PDF ↗ |
| K070330 | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM | Avantis Medical Systems, Inc. | 2007-04-24 | Traditional | PDF ↗ |
| K063585 | KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM | KARL STORZ Endoscopy-America, Inc. | 2007-01-31 | Traditional | PDF ↗ |
| K063654 | ENDOGUIDE | Kms Medical, LLC | 2007-01-31 | Traditional | PDF ↗ |
| K052930 | NAVIGATOR ENDOSCOPY SYSTEM | Neoguide Systems, Inc. | 2006-01-31 | Traditional | PDF ↗ |
| K051068 | ZUTRON COLONOSCOPE STIFFENING DEVICE | Zutron Medical | 2005-07-11 | Traditional | PDF ↗ |
| K051541 | GF-UE160-AL5 ULTRASOUND ENDOSCOPE | Olympus America, Inc. | 2005-07-01 | Traditional | PDF ↗ |
| K043487 | EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 | Aizu Olympus Co., Ltd. | 2005-01-28 | Traditional | PDF ↗ |
| K041903 | FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 | Fujinon, Inc. | 2004-11-10 | Traditional | PDF ↗ |
| K032688 | COLONOSIGHT MODEL 510B | Sightline Technologies , Ltd. | 2004-03-05 | Traditional | PDF ↗ |
| K023259 | INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 | Helix Medical, Inc. | 2002-12-26 | Traditional | PDF ↗ |
| K002749 | ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D | The Olympus Optical Co. | 2000-12-04 | Traditional | PDF ↗ |
| K001241 | EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I | The Olympus Optical Co. | 2000-05-09 | Special | PDF ↗ |
| K970372 | GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS | Precision Endoscopy of America, Inc. | 1997-03-11 | Traditional | PDF ↗ |
| K961570 | KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH) | Pentax Precision Instrument Corp. | 1996-06-24 | Traditional | PDF ↗ |
| K961563 | EC-384OTL, VIDEO COLONSCOPE | Pentax Precision Instrument Corp. | 1996-06-19 | Traditional | PDF ↗ |
| K951574 | EC-3800L, VIDEO COLONOSCOPE | Pentax Precision Instrument Corp. | 1996-03-21 | Traditional | PDF ↗ |
| K951579 | EC-3800TL, VIDEO COLONOSCOPE | Pentax Precision Instrument Corp. | 1996-03-21 | Traditional | PDF ↗ |
Product code FDF · Class II · Gastroenterology, Urology. Data: openFDA.