K133316

Substantially Equivalent

SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)

Applicant: Epimed International, Inc.
Product code: BSO
Advisory panel: Anesthesiology
Date received: 2013-10-28
Decision date: 2014-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Johnstown, NY, US

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.