FDA 510(k): NaviCam Xpress Stomach Capsule Endoscopy System (K241934)
[in effect]United States · permit · permit
Jurisdiction
United States
Classification
permit
Status
in effect
Effective Date
Dec 1, 2024
Primary Sources
1 audited
Statutory Scope & Summary
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.
Covered Sectors & Application Domains
Regulatory Analysis & Inquiries
6 entriesWhat 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.
Primary Sources & Legal Instruments
1 document- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241934Official Source
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241934