K233069 is an FDA 510(k) clearance for the Removal System Large Bore 60 cc Syringe. This device is classified as a Vacuum Syringe (Class II - Special Controls, product code PUR).
Submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on March 26, 2024, 182 days after receiving the submission on September 26, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860. 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) Number | K233069 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2023 |
| Decision Date | March 26, 2024 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PUR — Vacuum Syringe |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
| 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. |