BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL— 510(k) K020867

Substantially Equivalent

Worldwide Medical Technologies, LLC

FDA 510(k) clearance K020867 for BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL, Substantially Equivalent on 2002-05-20. Applicant: Worldwide Medical Technologies, LLC.

Clearance details

Applicant
Worldwide Medical Technologies, LLC
Product code
Code KNW
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Woodbury, CT, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KNW

product code KNW
Death
9
Injury
965
Malfunction
10,444
Other
3
Total
11,421

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.