NYVClass II
Gastrointestinal Motility System, Capsule
Gastroenterology, Urology · 21 CFR 876.1725
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
MDR events30All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances5All time
Recent MDR events
30 adverse event reports on file
- UNKNOWN SMARTPILLApr 15, 2025InjuryGiven Imaging Ltd., Yoqneam9710107-2025-00158
- SMARTPILLAug 26, 2024MalfunctionGiven Imaging Ltd., Yoqneam9710107-2024-00145
- SMARTPILLAug 26, 2024MalfunctionGiven Imaging Ltd., Yoqneam9710107-2024-00146
- SMARTPILLAug 26, 2024MalfunctionGiven Imaging Ltd., Yoqneam9710107-2024-00147
- SMARTPILLAug 26, 2024MalfunctionGiven Imaging Ltd., Yoqneam9710107-2024-00148
- SMARTPILLAug 23, 2024MalfunctionGiven Imaging Ltd., Yoqneam9710107-2024-00141
- SMARTPILLAug 22, 2024MalfunctionGiven Imaging Ltd., Yoqneam9710107-2024-00139
- SMARTPILLAug 22, 2024MalfunctionGiven Imaging Ltd., Yoqneam9710107-2024-00143
- SMARTPILLAug 22, 2024MalfunctionGiven Imaging Ltd., Yoqneam9710107-2024-00140
- SMARTPILLAug 22, 2024MalfunctionGiven Imaging Ltd., Yoqneam9710107-2024-00142
Event type breakdown
Injury17
Malfunction12
Other1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Atmo Biosciences, Ltd.May 22, 2026
K253569 · Atmo Gas Capsule System
- Atmo Biosciences, Ltd.Jun 26, 2025
K250940 · Atmo Gas Capsule System
- Anx Robotica CorporationMay 21, 2025
K250493 · MotiliCap GI Monitoring System
- The Smartpill CorporationOct 30, 2009
K092342 · SMARTPILL GI MONITORING SYSTEM, VERSION 2.0
- The Smartpill CorporationJul 18, 2006
K053547 · SMARTPILL GI MONITORING SYSTEM