510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212954Substantially Equivalent

G-Tech Wireless Patch System (WPS)

G-TECH MEDICAL Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212954 is the FDA 510(k) clearance record for G-Tech Wireless Patch System (WPS), a class II device, cleared for G-Tech Medical on under FDA product code MYE (System, Electrogastrography (Egg)). FDA records list one 510(k) clearance for G-Tech Medical. As of , FDA records show no recalls naming K212954.

Clearance record

Decision date
Received
(116 days to decision)
Product code
MYE System, Electrogastrography (Egg)
Regulation
21 CFR 876.1735
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
G-Tech Medical 2495 Hospital Dr., Suite 300, Mountain View CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MYE

Trailing 12 months
2 clearances under product code MYE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MYE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260