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Regulation · Permit

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

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.

Jurisdiction: United States · Effective 2024-12-01

Machine-readable surfaces

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.
Methodology: Unreviewed · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Architectural position

Cohort: surgical

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934).

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