DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of…
DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o’clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions. This DiLumen C2 version is designed to be used with the DiLumen Elbow Ig grasper.
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 C2 | 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) | K173317 |
| Record published | 2019-12-26 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| 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.