| K-number | K252480 |
| Device name | CE Deliver (DLV) |
| Applicant | CapsoVision, Inc. |
| Product code | NEZ |
| Device class | Class II |
| Decision date | Dec 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1300 |
The CE Deliver (DLV) is a single-use, disposable catheter-based delivery device designed to transendoscopically deliver CapsoCam Plus capsule endoscopes to the stomach or duodenum. It is intended for patients unable to swallow capsule endoscopes or unable to pass them beyond the pylorus in adequate time to complete diagnostic evaluation.
The CE Deliver is a 2.5mm single-sheathed flexible catheter with a detachable capsule holder at its distal end and a handle at its proximal end. It uses a wire-based 'push off' deployment mechanism to facilitate capsule release and is compatible with upper endoscopes having an instrument channel diameter of 2.8mm or larger.
Not stated in this summary.
The proposed CE Deliver has the same intended use as the predicate device (AdvanCE Capsule Endoscope Delivery Device, K163495). Both are single-use, disposable devices designed for transendoscopic delivery of capsule endoscopes to patients unable to swallow or pass capsules beyond the pylorus. The devices share the same fundamental scientific technology and operating principles; minor design differences in the capsule holder and implementation do not raise new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov