510(k) K244029
- Device
- ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
- Applicant
- Endorobotics Co., Ltd.
- 510(k) number
- K244029
- Product code
- FDF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-24
- Date received
- 2024-12-30
- Regulation
- 876.1500
- Classification name
- Colonoscope And Accessories, Flexible/Rigid
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jihwan Kim
- Address
- 3rd Floor, Dusan-Bears Tower 81, Wangsa-Ro, Dongdaemun-Gu Seoul KR 02577 02577
FDA Registration Numbers#
- 3009698186
- 3024021261
- 3018258446
- 2528981
- 3004705634
- 3014605202
- 3010288205
- 3021008900
- 1651395
- 3015525240
- 3013505983
- 3002807314
- 3042225166
- 1000121056
- 3011416394
- 3011816755
- 8010047
- 3011050570
- 3010202439
- 1047843
- 2011171
- 3006161756
- 3004052101
- 3028058843
- 2950776
- 9616684
- 1220477
- 3010703925
- 3005261802
- 3010229237
- 9611112
- 1221826
- 3008386005
- 3004111573
- 3042172882
- 3003775006
- 2020550
- 3002808148
- 3013944123
- 9610595
- 3014769442
- 3006546082
- 3013184907
- 2246552
- 3012414760
- 3004644065
- 3004016520
- 3002808022
- 3005099803
- 3021246306
- 9614641
- 3023102955
- 9611680
- 3012843412
- 1528319
- 3015451828
- 3005814162
- 9681260
- 3015136743
- 3022106566
- 3017210488
- 3008797804
- 3008879776
- 3015746529
- 9610877
- 3010390468
- 3010707607
- 3003637092
- 9610617
- 3003782610
- 3010009693
- 3014342096
- 3020707080
- 3014279513
- 3009420598
- 1222928
- 3013023255
Source Documents#
Other 510(k) Records For Product Code FDF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252457 | Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2026-01-30 |
| 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 |