FDF — Colonoscope And Accessories, Flexible/Rigid Class II
FDA product code FDF covers "Colonoscope And Accessories, Flexible/Rigid", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261587 | bpendo | Insufflation Retention Device (IRD) (11173-325-101) | July 2, 2026 |
| K260423 | yangzhou fartley medical instrument technology co | Disposable Endoscopic Distal Attachments | May 28, 2026 |
| 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 |