TISSUE PROCESSING SYSTEM— 510(k) K801513

Substantially Equivalent

Innovative Medical Systems, Inc.

FDA 510(k) clearance K801513 for TISSUE PROCESSING SYSTEM, Substantially Equivalent on 1980-07-28. Applicant: Innovative Medical Systems, Inc..

Clearance details

Applicant: Innovative Medical Systems, Inc.
Product code: Code IEO
Advisory panel: Pathology
Date received: 1980-06-30
Decision date: 1980-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code IEO

product code IEO

Injury: 326
Total: 326

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.