OJA — Intravenous Extension Tubing Set Class II
FDA product code OJA covers "Intravenous Extension Tubing Set", a Class II medical device regulated under 21 CFR 880.5440. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OJA
- Device Class
- Class II
- Regulation Number
- 880.5440
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- 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 |
|---|---|---|---|
| K873109 | life-tech intl | MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET | August 28, 1987 |