Atmo Gas Capsule System
FDA 510(k) clearance K250940 · decided 2025-06-26
Clearance details
- K-number
- K250940
- Device name
- Atmo Gas Capsule System
- Applicant
- Atmo Biosciences, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-28
- Decision date
- 2025-06-26
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NYV
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Box Hill, AU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Atmo Gas Capsule System (K253569) | Atmo Biosciences, Ltd. | 2026-05-22 |
| MotiliCap GI Monitoring System (K250493) | Anx Robotica Corporation | 2025-05-21 |
| SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 (K092342) | The Smartpill Corporation | 2009-10-30 |
| SMARTPILL GI MONITORING SYSTEM (K053547) | The Smartpill Corporation | 2006-07-18 |
Recalls involving this device
No recalls on record reference this clearance.