FDF — Colonoscope And Accessories, Flexible/Rigid Class II
Classification Details
- Product Code
- FDF
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252457 | shanghai seegen photoelectric technology co | Disposable Distal End Tape Hood | January 30, 2026 |
| K244029 | endorobotics co | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | September 24, 2025 |
| K243261 | fujifilm corporation | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM | May 23, 2025 |
| K250432 | olympus medical systems corporation | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal | May 15, 2025 |
| K242110 | pentax of america | PENTAX Medical Video Colonoscope (EC38-i20cWL) | January 3, 2025 |
| K242325 | actuated medical | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | October 4, 2024 |
| K232043 | guangzhou red pine medical instrument co | Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, | February 16, 2024 |
| K231254 | actuated medical | GripTract-GI Endoscopic Tissue Manipulator | November 3, 2023 |
| K232922 | motus gi medical technologies | Pure-Vu EVS System | October 20, 2023 |
| K230332 | ambu | Ambu® aScope Colon; Ambu® aBox 2 | September 15, 2023 |
| K223827 | fujifilm corporation | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | September 8, 2023 |
| K230588 | gi view | Aer-O-Scope Colonoscope System | August 17, 2023 |
| K221452 | lumendi | DiLumen C1, EZ1 and Tool Mount | February 10, 2023 |
| K213773 | bpendo | Insufflation Retention Device | July 21, 2022 |
| K220158 | smart medical systems | G-EYE System | April 11, 2022 |
| K213578 | hangzhou ags medtech co | Balloon Dilatation Catheter | April 6, 2022 |
| K210052 | saneso | Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with | April 1, 2022 |
| K220007 | motus gi medical technologies | Pure-Vu EVS System | February 10, 2022 |
| K211819 | lumendi | DiLumen C2 and Tool Mount | October 22, 2021 |
| K210981 | motus gi medical technologies | Pure Vu System | April 29, 2021 |