EP-100 (SERIES)— 510(k) K884415

Substantially Equivalent

Stereotactic Medical Systems, Inc.

FDA 510(k) clearance K884415 for EP-100 (SERIES), Substantially Equivalent on 1989-02-28. Applicant: Stereotactic Medical Systems, Inc..

Clearance details

Applicant: Stereotactic Medical Systems, Inc.
Product code: Code FPD
Advisory panel: Gastroenterology, Urology
Date received: 1988-10-20
Decision date: 1989-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Valley City, UT, US

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Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.