NXA — Tracheotomy Care Kit Class II
FDA product code NXA covers "Tracheotomy Care Kit", a Class II medical device regulated under 21 CFR 868.5800. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NXA
- Device Class
- Class II
- Regulation Number
- 868.5800
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- 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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K844051 | washington-greene county branch pennsylvania assoc | SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT | January 18, 1985 |