_Regulation · Permit_

# FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934)

Canonical ID: `7b8bb2b3-5e15-4e80-b372-b2f5fe6fe871`

- **Jurisdiction:** [United States](/locations/united-states.md) (id: `aa8b9c05-c836-4021-801f-59801970401e`)
- **Kind:** `permit`
- **Status (derived):** in_effect
- **Effective:** 2024-12-01

FDA cleared the NaviCam Xpress Stomach Capsule Endoscopy System, a magnetically maneuvered capsule endoscopy system for stomach examination. Enables non-invasive gastric visualization without traditional endoscopy.

## Sources (1)

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241934

## Status history

- **in_effect** · 2024-12-01 · agent-recon
    - Initial ingestion

## Common questions

### What does FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934) cover?

FDA cleared the NaviCam Xpress Stomach Capsule Endoscopy System, a magnetically maneuvered capsule endoscopy system for stomach examination. Enables non-invasive gastric visualization without traditional endoscopy.

### Where does FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934) apply?

FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934) is recorded as a permitting requirement applying in United States on the DEPLOY registry.

### When did FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934) take effect?

FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934) is recorded as effective December 1, 2024 on the DEPLOY registry.

### Is FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934) still in effect?

FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934) is currently in effect and applies to covered operators in the named jurisdiction.

### What types of robots does FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934) apply to?

FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934) is recorded as applying to surgical on the DEPLOY registry.

### Which robot models on the DEPLOY registry fall under FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934)?

8 robot models on the DEPLOY registry match the form-factor scope of FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934): ANOVO, Andromeda Surgical Robot, CORI, Carina and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.


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