DeviceClearance

TRUEdraw Lancing Device, Mini Lancing Device— 510(k) K221072

Substantially Equivalent

Trividia Health

FDA 510(k) clearance K221072 for TRUEdraw Lancing Device, Mini Lancing Device, Substantially Equivalent on 2022-10-18. Applicant: Trividia Health. Device class: 2.

Clearance details

Applicant
Trividia Health
Product code
Code QRL
Device class
Class 2
Regulation
21 CFR 878.4850
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fort Lauderdale, FL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code QRL

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Adverse events under product code QRL

product code QRL
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.