The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and…
The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen C1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope. The device also has one integrated, flexible tool channel that provides access at the therapeutic site to use flexible endoscopic tools such as graspers, scissors, knives, etc., to perform endoluminal interventions.
Who Else Makes It
Concentrated in Shanghai (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for DiLumen C1, 103 cm | Listed by | Lumendi, LLC, United States |
| FDA product code | FDF |
| Device type | Colonoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K221452 |
| Record published | 2023-05-01 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.