Product code FDF
- Device name
- Colonoscope And Accessories, Flexible/Rigid
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252457 | Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2026-01-30 |
| K244029 | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | Endorobotics Co., Ltd. | 2025-09-24 |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L | Fujifilm Corporation | 2025-05-23 |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) | Olympus Medical Systems Corporation | 2025-05-15 |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | Pentax of America, Inc. | 2025-01-03 |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | Actuated Medical, Inc. | 2024-10-04 |
| 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 |
| K231254 | GripTract-GI Endoscopic Tissue Manipulator | Actuated Medical, Inc. | 2023-11-03 |
| K232922 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | 2023-10-20 |
| K230332 | Ambu® aScope™ Colon; Ambu® aBox™ 2 | Ambu A/S | 2023-09-15 |
| K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | 2023-09-08 |
| K230588 | Aer-O-Scope Colonoscope System | Gi View , Ltd. | 2023-08-17 |
| K221452 | DiLumen C1, EZ1 and Tool Mount | Lumendi, LLC | 2023-02-10 |
| K213773 | Insufflation Retention Device | Bpendo, LLC | 2022-07-21 |
| K220158 | G-EYE System | Smart Medical Systems , Ltd. | 2022-04-11 |
| K213578 | Balloon Dilatation Catheter | Hangzhou AGS MedTech Co., Ltd. | 2022-04-06 |
| 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/w... | Saneso, Inc. | 2022-04-01 |
| K220007 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | 2022-02-10 |
| K211819 | DiLumen C2 and Tool Mount | Lumendi, LLC | 2021-10-22 |
| K210981 | Pure Vu System | Motus GI Medical Technologies , Ltd. | 2021-04-29 |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi, LLC | 2021-04-21 |
| K202469 | G-EYE System | Smart Medical Systems , Ltd. | 2020-10-26 |
| 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 |
| K192588 | G-EYE System | Smart Medical Systems , Ltd. | 2020-04-15 |
| K190669 | Endotics | Era Endoscopy S.R.L. | 2020-01-03 |
| K192664 | FUJIFILM Endoscope Model EC-760Z-V/L | Fujifilm Corporation | 2019-11-20 |
| K191220 | Pure Vu System | Motus GI Medical Technologies , Ltd. | 2019-06-06 |
| K190649 | FUJIFILM Endoscope Model EC-760S-V/L | Fujifilm Corporation | 2019-05-07 |
| K181084 | PENTAX Video Colonoscopes (EC Family) | Pentax of America, Inc. | 2019-01-18 |
| K182540 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2018-10-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04953170467349 | ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5 | OLYMPUS MEDICAL SYSTEMS CORP. | 2025-09-25 |
| 14547410477242 | FUJIFILM | FUJIFILM CORPORATION | 2025-06-30 |
| 14547410477273 | FUJIFILM | FUJIFILM CORPORATION | 2025-06-30 |
| 14547410477303 | FUJIFILM | FUJIFILM CORPORATION | 2025-06-30 |
| 04953170425103 | COLONOVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2025-05-26 |
| 04953170425158 | COLONOVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORP. | 2025-05-26 |
| 04961333356478 | PENTAX Medical | HOYA CORPORATION | 2025-04-28 |
| 04961333129430 | PENTAX | HOYA CORPORATION | 2025-04-04 |
| 04961333172085 | PENTAX | HOYA CORPORATION | 2025-04-04 |
| 84953170463910 | BALLOON3 | OLYMPUS MEDICAL SYSTEMS CORP. | 2025-02-25 |
| 00850458007041 | GripTract-GI Endoscopic Tissue Manipulator | ACTUATED MEDICAL, INC. | 2025-01-16 |
| 04961333254620 | PENTAX Medical | HOYA CORPORATION | 2024-12-13 |
| 04953170465970 | EVIS EXERA III XENON LIGHT SOURCE | OLYMPUS MEDICAL SYSTEMS CORP. | 2024-11-25 |
| 04048551003701 | SILVER SCOPE | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 08714729339380 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339427 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339359 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339335 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729339328 | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 04048551003695 | SILVER SCOPE | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551054970 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551055045 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551055120 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551055441 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551057100 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551057179 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551057223 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551057247 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551228166 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551228241 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |