A-TAP (previously called Arthrotap)— 510(k) K231900

Name: FDA 510(k) clearance K231900
Creator: U.S. Food and Drug Administration
Published: 2023-07-25

Substantially Equivalent

Elcam Medical Acal

FDA 510(k) clearance K231900 for A-TAP (previously called Arthrotap), Substantially Equivalent on 2023-07-25. Applicant: Elcam Medical Acal. Device class: 2.

Clearance details

Applicant: Elcam Medical Acal
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2023-06-28
Decision date: 2023-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Baram, IL

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.