| 2026-07-02 |
K261587 |
BPEndo, LLC
|
Insufflation Retention Device (IRD) (11173-325-101) |
| 2026-05-28 |
K260423 |
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
|
Disposable Endoscopic Distal Attachments |
| 2026-01-30 |
K252457 |
Shanghai SeeGen Photoelectric Technology Co., Ltd.
|
Disposable Distal End Tape Hood |
| 2025-09-24 |
K244029 |
Endorobotics Co., Ltd.
|
ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) |
| 2025-05-23 |
K243261 |
Fujifilm Corporation
|
FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L |
| 2025-05-15 |
K250432 |
Olympus Medical Systems Corporation
|
Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) |
| 2025-01-03 |
K242110 |
Pentax of America, Inc.
|
PENTAX Medical Video Colonoscope (EC38-i20cWL) |
| 2024-10-04 |
K242325 |
Actuated Medical, Inc.
|
GripTract-GI Endoscopic Tissue Manipulator Lower GI Models |
| 2024-02-16 |
K232043 |
Guangzhou Red Pine Medical Instrument Co., Ltd.
|
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) |
| 2023-11-03 |
K231254 |
Actuated Medical, Inc.
|
GripTract-GI Endoscopic Tissue Manipulator |
| 2023-10-20 |
K232922 |
Motus GI Medical Technologies , Ltd.
|
Pure-Vu EVS System |
| 2023-09-15 |
K230332 |
Ambu A/S
|
Ambu® aScope Colon; Ambu® aBox 2 |
| 2023-09-08 |
K223827 |
Fujifilm Corporation
|
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 |
| 2023-08-17 |
K230588 |
Gi View , Ltd.
|
Aer-O-Scope Colonoscope System |
| 2023-02-10 |
K221452 |
Lumendi, LLC
|
DiLumen C1, EZ1 and Tool Mount |
| 2022-07-21 |
K213773 |
Bpendo, LLC
|
Insufflation Retention Device |
| 2022-04-11 |
K220158 |
Smart Medical Systems , Ltd.
|
G-EYE System |
| 2022-04-06 |
K213578 |
Hangzhou AGS MedTech Co., Ltd.
|
Balloon Dilatation Catheter |
| 2022-04-01 |
K210052 |
Saneso, Inc.
|
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)) |
| 2022-02-10 |
K220007 |
Motus GI Medical Technologies , Ltd.
|
Pure-Vu EVS System |
| 2021-10-22 |
K211819 |
Lumendi, LLC
|
DiLumen C2 and Tool Mount |
| 2021-04-29 |
K210981 |
Motus GI Medical Technologies , Ltd.
|
Pure Vu System |
| 2021-04-21 |
K210851 |
Lumendi, LLC
|
DiLumen Endolumenal Interventional Platform (DiLumen) |
| 2020-10-26 |
K202469 |
Smart Medical Systems , Ltd.
|
G-EYE System |
| 2020-07-17 |
K192793 |
Olympus Medical Systems Corp.
|
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 |