SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)— 510(k) K133316

Name: FDA 510(k) clearance K133316
Creator: U.S. Food and Drug Administration
Published: 2014-05-28

Substantially Equivalent

Epimed International, Inc.

FDA 510(k) clearance K133316 for SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS), Substantially Equivalent on 2014-05-28. Applicant: Epimed International, Inc.. Device class: 2.

Clearance details

Applicant: Epimed International, Inc.
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
Advisory panel: Anesthesiology
Date received: 2013-10-28
Decision date: 2014-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Johnstown, NY, US

Download summary PDF View on FDA.gov ↗

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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.