Device class
Class II
Regulation 876.1725
Total clearances
3
2025-05-21 → 2026-05-22
Definition
What is Gastrointestinal Motility System, Capsule
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.1725
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 91020 |
CPT
|
— |
High
|
Gastric motility (manometric) studies; esophageal studies including pressure tracing |
| 91010 |
CPT
|
— |
Medium
|
Esophageal motility (manometric) studies with interpretation and report |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-05-22 |
K253569 |
Atmo Biosciences, Ltd.
|
Atmo Gas Capsule System |
| 2025-06-26 |
K250940 |
Atmo Biosciences, Ltd.
|
Atmo Gas Capsule System |
| 2025-05-21 |
K250493 |
Anx Robotica Corporation
|
MotiliCap GI Monitoring System |