Flush Syringe (Prefilled 0.9% normal saline solution)— 510(k) K231724

Substantially Equivalent

Spm Medicare Pvt. , Ltd.

FDA 510(k) clearance K231724 for Flush Syringe (Prefilled 0.9% normal saline solution), Substantially Equivalent on 2023-11-09. Applicant: Spm Medicare Pvt. , Ltd..

Clearance details

Applicant
Spm Medicare Pvt. , Ltd.
Product code
Code NGT
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gautam Budh Nagar, IN
Download summary PDFView on FDA.gov ↗

Adverse events under product code NGT

product code NGT
Death
12
Malfunction
2,008
Other
4
Total
2,024

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.