CANCEL— 510(k) K812582

Substantially Equivalent

Bio Systems, Inc.

FDA 510(k) clearance K812582 for CANCEL, Substantially Equivalent on 1981-09-23. Applicant: Bio Systems, Inc..

Clearance details

Applicant: Bio Systems, Inc.
Product code: Code EXB
Advisory panel: Gastroenterology, Urology
Date received: 1981-09-10
Decision date: 1981-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EXB

product code EXB

Injury: 145
Total: 145

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.