EpiZact— 510(k) K233056

Name: FDA 510(k) clearance K233056
Creator: U.S. Food and Drug Administration
Published: 2023-11-02

Substantially Equivalent

Guidestar Medical Devices

FDA 510(k) clearance K233056 for EpiZact, Substantially Equivalent on 2023-11-02. Applicant: Guidestar Medical Devices. Device class: 2.

Clearance details

Applicant: Guidestar Medical Devices
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2023-09-25
Decision date: 2023-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victoria, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.