DeviceClearance

Product code LWE— Unknown

BONE MARROW COLLECTION KIT AND STAND

Classification name
Bone Marrow Collection/Transfusion Kit
Device class
Class 2
Advisory panel
Unknown
Total cleared
3
First cleared
Most recent

FDA classification definition

“This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.”

— U.S. Food and Drug Administration, device classification record for product code LWE, via openFDA

Market context for product code LWE

FDA has cleared 3 devices under product code LWE between 1987 and 1995, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code LWE

Recent clearances under product code LWE

Data sourced from openFDA. This site is unofficial and independent of the FDA.