Flexpen Needle
by Novo Nordisk, Inc. 2 variants
510(k) K062500
Flexpen Needle is a medical device (FDA Class II; FDA product code FMI, Needle, Hypodermic, Single Lumen) made by Novo Nordisk, Inc., cleared under FDA 510(k) K062500 on 21 Nov 2006, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062500 | Date21 Nov 2006 | StatusActive |
Official records
- FDA 510(k) database K062500
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FMI
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
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