Needle, Interosseous
The interosseous needle is a general hospital device used to establish intraosseous vascular access by penetrating bone cortex to reach the medullary cavity, enabling rapid infusion of fluids, blood products, and medications in emergency situations when conventional IV access is unavailable. It is classified as FDA Class II under 21 CFR 880.5570 within the General Hospital specialty, requiring 510(k) premarket clearance. The product code is MHC and it carries an implant flag reflecting its insertion into bone during use. Full GMP compliance is required.
Basic Information
- Product Code
- MHC
- Device Class
- FDA class 2
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | Nov 10, 2022 | Substantially Equivalent | Bard Access Systems |
| K203193 | BD Intraosseous Infusion System | Mar 04, 2021 | Substantially Equivalent | Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.