Safety Needle
510(k) K051019
Safety Needle is a medical device (FDA Class II; FDA product code JKA, Tubes, Vials, Systems, Serum Separators, Blood Collection) made by Sarstedt, Inc., cleared under FDA 510(k) K051019 on 25 Jul 2005, 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 | NumberK051019 | Date25 Jul 2005 | StatusActive |
Official records
- FDA 510(k) database K051019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JKA
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1675
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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