Gastric Alimetry System
FDA 510(k) clearance K213924 · decided 2022-06-03
Clearance details
- K-number
- K213924
- Device name
- Gastric Alimetry System
- Applicant
- Alimetry , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-15
- Decision date
- 2022-06-03
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- MYE
- Device class
- 2
- Regulation number
- 876.1735
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Grafton, NZ
- 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 |
|---|---|---|
| Gastric Alimetry (K252504) | Alimetry , Ltd. | 2025-12-05 |
| Gastric Alimetry (K240946) | Alimetry , Ltd. | 2024-07-03 |
| Gastric Alimetry System (K232925) | Alimetry , Ltd. | 2023-11-17 |
| Gastric Alimetry System (K223398) | Alimetry , Ltd. | 2023-04-27 |
| G-Tech Wireless Patch System (WPS) (K212954) | G-Tech Medical | 2022-01-10 |
| POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 (K014269) | Medtronic Functional Diagnostics A/S | 2002-11-21 |
| THE 3PM EGG MACHINE (DEN990005) | 3pm Co., Inc. | 1999-08-20 |
Recalls involving this device
No recalls on record reference this clearance.