K231724 is an FDA 510(k) clearance for the Flush Syringe (Prefilled 0.9% normal saline solution). This device is classified as a Saline, Vascular Access Flush (Class II - Special Controls, product code NGT).
Submitted by Spm Medicare Pvt. , Ltd. (Gautam Budh Nagar, IN). The FDA issued a Cleared decision on November 9, 2023, 149 days after receiving the submission on June 13, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200. Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use..
| 510(k) Number | K231724 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2023 |
| Decision Date | November 09, 2023 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | NGT - Saline, Vascular Access Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
| Definition | Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use. |