Flush Syringe (Prefilled 0.9% normal saline solution)
K-Number: K231724 · 2023-11-09
ApplicantSpm Medicare Pvt. , Ltd.
Decision Date2023-11-09
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Flush Syringe (Prefilled 0.9% normal saline solution) is a medical device manufactured by Spm Medicare Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-11-09 under approval number K231724. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Flush Syringe (Prefilled 0.9% normal saline solution)?
Flush Syringe (Prefilled 0.9% normal saline solution) is a medical device that received FDA 510(k) clearance on 2023-11-09. It is manufactured by Spm Medicare Pvt. , Ltd.. The 510(k) number is K231724.
When was Flush Syringe (Prefilled 0.9% normal saline solution) approved by the FDA?
Flush Syringe (Prefilled 0.9% normal saline solution) received FDA 510(k) clearance on 2023-11-09, under approval number K231724.
What company makes Flush Syringe (Prefilled 0.9% normal saline solution)?
Flush Syringe (Prefilled 0.9% normal saline solution) is manufactured by Spm Medicare Pvt. , Ltd..
What is the FDA product code for Flush Syringe (Prefilled 0.9% normal saline solution)?
The FDA product code for Flush Syringe (Prefilled 0.9% normal saline solution) is NGT.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.