Electrosurgical Electrode Kit
The Electrosurgical Electrode Kit (product code NWI) is a convenience kit used in electrosurgical procedures, regulated under 21 CFR 876.4300 within the Gastroenterology and Urology specialty. It is classified as FDA Class 2, and as a convenience kit established under the May 1997 Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) submission to market provided it meets all criteria in that guidance. The device has no implant or life-sustaining flags.
Basic Information
- Product Code
- NWI
- Device Class
- FDA class 2
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 7
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.