Freedom Syringe
510(k) K161812
Freedom Syringe is a medical device (FDA Class II; FDA product code FMF, Syringe, Piston) made by Procedure Products, Inc., cleared under FDA 510(k) K161812 on 27 Mar 2017, 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 | NumberK161812 | Date27 Mar 2017 | StatusActive |
Official records
- FDA 510(k) database K161812
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FMF
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K161812
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Freedom Syringe 1001-R | 1001-R | B1601001R1 | — | On the market |
| Freedom Syringe 1003-G | 1003-G | B1601003G1 | — | On the market |
| Freedom Syringe 1006-B | 1006-B | B1601006B1 | — | On the market |
| Freedom Syringe 1010-B | 1010-B | B1601010B1 | — | On the market |
| Freedom Syringe 1020-W | 1020-W | B1601020W1 | — | On the market |
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Other devices filed under FDA product code FMF (Syringe, Piston).
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