FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
FDA 510(k) clearance K243261 · decided 2025-05-23
Clearance details
- K-number
- K243261
- Device name
- FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
- Applicant
- Fujifilm Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-10-15
- Decision date
- 2025-05-23
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- FDF
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ashigara Kami-Gun, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Insufflation Retention Device (IRD) (11173-325-101) (K261587) | BPEndo, LLC | 2026-07-02 |
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| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.