NWN — Laparoscopic Bone Anchor Urethropexy Instrument Kit Class II
FDA product code NWN covers "Laparoscopic Bone Anchor Urethropexy Instrument Kit", a Class II medical device regulated under 21 CFR 888.3040. Submissions are reviewed by the Orthopedic panel.
Classification Details
- Product Code
- NWN
- Device Class
- Class II
- Regulation Number
- 888.3040
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.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.