FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy
[in effect]United States · permit · permit
Jurisdiction
United States
Classification
permit
Status
in effect
Effective Date
Nov 15, 2021
Primary Sources
1 audited
Statutory Scope & Summary
FDA granted 510(k) clearance for Medtronic PillCam Small Bowel 3 system for remote endoscopy procedures, enabling at-home capsule endoscopy. The system allows patients to undergo small bowel examination without visiting a clinical facility.
Covered Sectors & Application Domains
Regulatory Analysis & Inquiries
6 entriesWhat does FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy cover?
FDA granted 510(k) clearance for Medtronic PillCam Small Bowel 3 system for remote endoscopy procedures, enabling at-home capsule endoscopy. The system allows patients to undergo small bowel examination without visiting a clinical facility.
Where does FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy apply?
FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy is recorded as a permitting requirement applying in United States on the DEPLOY registry.
When did FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy take effect?
FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy is recorded as effective November 15, 2021 on the DEPLOY registry.
Is FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy still in effect?
FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy is currently in effect and applies to covered operators in the named jurisdiction.
What types of robots does FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy apply to?
FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy is recorded as applying to surgical, wearable on the DEPLOY registry.
Which robot models on the DEPLOY registry fall under FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy?
8 robot models on the DEPLOY registry match the form-factor scope of FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy: AI Pin, ANOVO, AirGo Vision, Andromeda Surgical Robot 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://news.medtronic.com/2021-11-15-Medtronic-announces-510-k-clearance-for-PillCam-TM-Small-Bowel-3-HOME-endoscopy-procedureOfficial Source
https://news.medtronic.com/2021-11-15-Medtronic-announces-510-k-clearance-for-PillCam-TM-Small-Bowel-3-HOME-endoscopy-procedure