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Regulation · Permit

FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy

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.

Jurisdiction: United States · Effective 2021-11-15

Machine-readable surfaces

Sources (1)

  1. https://news.medtronic.com/2021-11-15-Medtronic-announces-510-k-clearance-for-PillCam-TM-Small-Bowel-3-HOME-endoscopy-procedure

Status history

  • In effect · 2021-11-15 · agent-recon

    Initial ingestion

Common questions

What 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.
Methodology: Unreviewed · 1 source (no 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
unclassified
Unclassified source

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

Methodology surface for FDA 510(k): Medtronic PillCam Small Bowel 3 Remote Endoscopy.

Canonical ID 0fb782ea-3ab2-4f1f-99fe-5dcf7c137f8f