Fuse Colonoscopy System
FDA 510(k) K141598 · Endochoice, Inc.
510(k) numberK141598
Submission
- Device name
- Fuse Colonoscopy System
- Applicant
- Endochoice, Inc.
Caesarea, IL - Received
- June 13, 2014
- Decision date
- September 30, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDF – Colonoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
Other 510(k)s with product code FDF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260503 | Triton 1 SystemFDF · Traditional | Neptune Medical, Inc. | 09/03/2026SE |
| K261015 | Solo Scope Colonoscope SystemFDF · Traditional | Gi View, Ltd. | 08/21/2026SE |
| K261587 | Insufflation Retention Device (IRD) (11173-325-101)FDF · Special | BPEndo, LLC | 07/02/2026SE |
| K260423 | Disposable Endoscopic Distal AttachmentsFDF · Traditional | Yangzhou Fartley Medical Instrument Technology… | 05/28/2026SE |
| K252457 | Disposable Distal End Tape HoodFDF · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 01/30/2026SE |
| K244029 | Robopera (ER-R-002); Robopera (ER-R-003)FDF · Traditional | Endorobotics Co., Ltd. | 09/24/2025SE |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…FDF · Traditional | Fujifilm Corporation | 05/23/2025SE |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…FDF · Traditional | Olympus Medical Systems Corporation | 05/15/2025SE |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF · Traditional | Pentax of America, Inc. | 01/03/2025SE |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsFDF · Traditional | Actuated Medical, Inc. | 10/04/2024SE |
More from Actuated Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160275 | Fuse Endoscopic System with FuseBox ProcessorPEA · Traditional | 08/01/2016SE |
| K161482 | EndoChoice Water Bottle Cap Irrigation SystemFEQ · Special | 06/27/2016SE |
| K161167 | Seal Single-Use Biopsy ValveOCX · Special | 05/26/2016SE |
| K160403 | SmartStart Air/Water and Suction ValvesODC · Traditional | 05/19/2016SE |
| K153588 | EndoChoice Water Bottle Cap SystemFEQ · Special | 02/24/2016SE |
| K151475 | EndoChoice Select Injection NeedleFBK · Traditional | 02/08/2016SE |
| K152182 | Fuse Gastroscopy SystemFDS · Special | 12/10/2015SE |
| K152580 | rescuenetFDI · Traditional | 11/03/2015SE |
| K142155 | Endochoice Water Bottle Cap SystemFEQ · Traditional | 01/20/2015SE |
| K140472 | Bonastent Tracheal / BronchialJCT · Traditional | 10/17/2014SE |
Questions and answers
When was Fuse Colonoscopy System cleared by the FDA?
Fuse Colonoscopy System (K141598) received a 510(k) decision of Substantially Equivalent on September 30, 2014, 109 days after the submission was received.
What is the product code of K141598?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.