ZINETICS AMC— 510(k) K921682

Substantially Equivalent

Zinetics Medical, Inc.

FDA 510(k) clearance K921682 for ZINETICS AMC, Substantially Equivalent on 1994-12-29. Applicant: Zinetics Medical, Inc..

Clearance details

Applicant: Zinetics Medical, Inc.
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 1992-04-08
Decision date: 1994-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code FFX

product code FFX

Other: 1
Total: 1

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.