FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CE Deliver (DLV)
K Number: K252480
·
Decision Dec 19, 2025
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
46
Applicant Total
6
Review Days
134
Basic Information
- Device Name
- CE Deliver (DLV)
- K Number
- K252480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CapsoVision, Inc.
- Date Received
- August 7, 2025
- Decision Date
- December 19, 2025
- Product Code
- NEZ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by CapsoVision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | Dec 4, 2024 | Substantially Equivalent |
| K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy System | Feb 14, 2020 | Substantially Equivalent |
| K183192 | CapsoCam Plus (SV-3) | Apr 19, 2019 | Substantially Equivalent |
| K161773 | CapsoCam Plus (SV-3) Capsule Endoscope System | Oct 21, 2016 | Substantially Equivalent |
| K151635 | CapsoCam (SV-1) | Feb 9, 2016 | Substantially Equivalent |