LWE — Bone Marrow Collection/Transfusion Kit Class II
FDA product code LWE covers "Bone Marrow Collection/Transfusion Kit", a Class II medical device. Submissions are reviewed by the Unknown panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LWE
- Device Class
- Class II
- Regulation Number
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Unknown
- Implant
- No
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.