G-Tech Wireless Patch System (WPS)
FDA 510(k) K212954 · G-Tech Medical
510(k) numberK212954
Submission
- Device name
- G-Tech Wireless Patch System (WPS)
- Applicant
- G-Tech Medical
Mountain View, CA, US - Received
- September 16, 2021
- Decision date
- January 10, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYE – System, Electrogastrography (Egg)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1735
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code MYE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262292 | Gastric AlimetryMYE · Traditional | Alimetry , Ltd. | 09/04/2026SE |
| K252504 | Gastric AlimetryMYE · Traditional | Alimetry , Ltd. | 12/05/2025SE |
| K240946 | Gastric AlimetryMYE · Traditional | Alimetry , Ltd. | 07/03/2024SE |
| K232925 | Gastric Alimetry SystemMYE · Traditional | Alimetry , Ltd. | 11/17/2023SE |
| K223398 | Gastric Alimetry SystemMYE · Traditional | Alimetry , Ltd. | 04/27/2023SE |
| K213924 | Gastric Alimetry SystemMYE · Traditional | Alimetry , Ltd. | 06/03/2022SE |
| K014269 | Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf Id…MYE · Traditional | Medtronic Functional Diagnostics A/S | 11/21/2002SE |
Questions and answers
When was G-Tech Wireless Patch System (WPS) cleared by the FDA?
G-Tech Wireless Patch System (WPS) (K212954) received a 510(k) decision of Substantially Equivalent on January 10, 2022, 116 days after the submission was received.
What is the product code of K212954?
The FDA product code is MYE – System, Electrogastrography (Egg), a Class II (moderate risk) device regulated under 21 CFR 876.1735.