FDA 510(k)

ProSeal In Line Pump Set (423850)

K-Number: K241735 · 2024-10-10

Decision Date2024-10-10

Product CodeONB

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ProSeal In Line Pump Set (423850) is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2024-10-10 under approval number K241735. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProSeal In Line Pump Set (423850)?

ProSeal In Line Pump Set (423850) is a medical device that received FDA 510(k) clearance on 2024-10-10. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K241735.

When was ProSeal In Line Pump Set (423850) approved by the FDA?

ProSeal In Line Pump Set (423850) received FDA 510(k) clearance on 2024-10-10, under approval number K241735.

What company makes ProSeal In Line Pump Set (423850)?

ProSeal In Line Pump Set (423850) is manufactured by Epic Medical Pte. , Ltd..

What is the FDA product code for ProSeal In Line Pump Set (423850)?

The FDA product code for ProSeal In Line Pump Set (423850) is ONB.

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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.