Freedom Syringe 1006-B
Freedom Syringe 1006-B is a general-purpose syringe (FDA Class II; FDA product code FMF, Syringe, Piston) made by Procedure Products, Inc., cleared under FDA 510(k) K161812 on 27 Mar 2017 and listed in FDA GUDID since 31 Aug 2020 (UDI-DI B1601006B1), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB1601006B1 | Date31 Aug 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161812 | Date27 Mar 2017 | StatusActive |
Official records
- FDA 510(k) database K161812
Across registries
- FDA 510(k) K161812 decided 27 Mar 2017 Active
- FDA GUDID UDI-DI B1601006B1 listed 31 Aug 2020 Listed
Timeline
- Cleared FDA 510(k) K161812
- Listed FDA GUDID B1601006B1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Freedom Syringe
- Generic name
- General-purpose syringe, single-use
- Model / reference
- 1006-B
- Primary DI / UDI-DI
- B1601006B1
- 510(k) Number
- FDA product code
- FMF
- GMDN term
- General-purpose syringe, single-use
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under General-purpose syringe, single-use.