PUR
- Product code
- PUR
- Device name
- Vacuum Syringe
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5860
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
The vacuum syringe is intended to be used as a general purpose syringe for injection and withdrawal of fluids and can be locked in place to create a vacuum for removal of fluid and/or tissue from the body in the form of thrombus, abscess fluid, and infected fluid.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233069 | 2024-03-26 | Inari Medical, Inc. | Removal System Large Bore 60 cc Syringe |
Official FDA classification page: PUR
Classification and pathway per current FDA publications. Data from openFDA (CC0).