_Regulation · Permit_

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

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

- **Jurisdiction:** [United States](/locations/united-states.md) (id: `aa8b9c05-c836-4021-801f-59801970401e`)
- **Kind:** `permit`
- **Status (derived):** in_effect
- **Effective:** 2021-11-15

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.

## 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.


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