ZINETICS GASTROMETER (TM)— 510(k) K862727

Substantially Equivalent

Zinetics Medical Technology Corp.

FDA 510(k) clearance K862727 for ZINETICS GASTROMETER (TM), Substantially Equivalent on 1986-11-19. Applicant: Zinetics Medical Technology Corp..

Clearance details

Applicant: Zinetics Medical Technology Corp.
Product code: Code FFT
Advisory panel: Gastroenterology, Urology
Date received: 1986-07-18
Decision date: 1986-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code FFT

product code FFT

Injury: 595
Malfunction: 2,175
Other: 1
Total: 2,771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.