BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets— 510(k) K223243

Substantially Equivalent

Becton, Dickinson and Company

FDA 510(k) clearance K223243 for BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets, Substantially Equivalent on 2022-12-16. Applicant: Becton, Dickinson and Company.

Clearance details

Applicant
Becton, Dickinson and Company
Product code
Code FMK
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Franklin Lakes, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FMK

product code FMK
Injury
133
Malfunction
1,278
Other
1
Total
1,412

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.