BACSTOP— 510(k) K053405

Name: FDA 510(k) clearance K053405
Creator: U.S. Food and Drug Administration
Published: 2006-05-11

Substantially Equivalent

Elcam Medical Acal

FDA 510(k) clearance K053405 for BACSTOP, Substantially Equivalent on 2006-05-11. Applicant: Elcam Medical Acal. Device class: 2.

Clearance details

Applicant: Elcam Medical Acal
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2005-12-07
Decision date: 2006-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mp. Merom Hagalil, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.