CapsoCam Plus (SV-3) Capsule Endoscopy System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192662 FDA 510(k)
- FDA Product Code
- NEZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1300 FDA 510(k)
- Regulation Number
- 876.1300 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CapsoCam Plus (SV-3) Capsule Endoscopy System is a wireless, ingestible imaging device classified as a gastrointestinal capsule endoscope. It captures high-resolution video of the small intestine and gastrointestinal tract as it passes naturally through the digestive system, enabling non-invasive visualization of the mucosal lining for diagnostic purposes.
This system is supplied as a reusable imaging device paired with disposable capsules containing the imaging sensor. It is intended for use in clinical settings such as gastroenterology and urology, with FDA clearance under a 510(k) submission (K192662) and compliance with EU MDR. The system operates without MRI restrictions and requires proper storage and handling as specified in the manufacturer’s instructions to maintain performance and sterility.
Frequently asked questions
What clinical specialties is the CapsoCam Plus (SV-3) Capsule Endoscopy System primarily used in, and why?
The CapsoCam Plus (SV-3) is primarily used in gastroenterology and urology based on its classification and advisory committee designation. This system is designed for non-invasive visualization of the gastrointestinal tract, including the small intestine, which is critical for diagnosing conditions like Crohn’s disease, small bowel tumors, or obscure gastrointestinal bleeding. In urology, it may also assist in evaluating urinary tract anomalies or foreign bodies when ingested with contrast. The system’s wireless, ingestible design aligns with diagnostic needs in these specialties.
Is the imaging device itself single-use or reusable, and how does the disposable component factor into its use?
The imaging device in the CapsoCam Plus (SV-3) system is reusable, while the capsules containing the imaging sensor are disposable. This design allows the core electronics and recording components to be reused across multiple procedures, reducing costs over time. Each patient receives a fresh, sterile capsule for ingestion, ensuring hygiene and compliance with clinical protocols for single-use consumables.
What storage requirements should I follow to maintain the performance and sterility of the disposable capsules?
The disposable capsules must be stored according to the manufacturer’s instructions to preserve sterility and performance. While specifics aren’t detailed here, typical guidelines for capsule endoscopy systems include keeping them in a cool, dry environment, protected from moisture and extreme temperatures. Always refer to the included packaging or CapsoVision’s instructions for exact storage conditions, as improper handling could compromise imaging quality or sterility.
Does this system have any restrictions on use with MRI machines, and why might that matter?
No, the CapsoCam Plus (SV-3) does not have MRI restrictions, meaning it can be used in patients who require MRI scans without interference. This is important because some ingestible devices contain metallic components that could pose risks in MRI environments, such as heating or image artifacts. The absence of such restrictions expands its usability in clinical settings where MRI is part of the diagnostic workflow.
How do I verify the regulatory compliance of this device for use in my facility?
The CapsoCam Plus (SV-3) holds FDA 510(k) clearance (K192662) and complies with EU MDR, confirming its regulatory standing in the U.S. and European markets. To verify compliance in your facility, check the device’s labeling for the FDA clearance number and CE marking (if applicable). Additionally, confirm that your institution’s procurement or medical device management team has reviewed the latest regulatory filings or manufacturer updates, as compliance may evolve. Always consult CapsoVision’s documentation or your facility’s compliance officer for the most current details.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192662 | Class II | Active |
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Manufacturer
- Manufacturer
- CapsoVision, Inc.
Sources (2)
- FDA 510(k) K192662 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026