NWU — Endoscope Introducer Kit Class II
FDA product code NWU covers "Endoscope Introducer Kit", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NWU
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- 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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.