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FDA 510(k)

ProSeal™ Closed System Administration Set

K-Number: K230343 · 2023-11-03

ApplicantEpic Medical Pte. , Ltd.
Decision Date2023-11-03
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ProSeal™ Closed System Administration Set is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K230343. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProSeal™ Closed System Administration Set?

ProSeal™ Closed System Administration Set is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K230343.

When did ProSeal™ Closed System Administration Set receive FDA 510(k) clearance?

ProSeal™ Closed System Administration Set received FDA 510(k) clearance on 2023-11-03, under 510(k) number K230343.

Who is the listed applicant for ProSeal™ Closed System Administration Set?

The FDA 510(k) record lists Epic Medical Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProSeal™ Closed System Administration Set?

The FDA product code for ProSeal™ Closed System Administration Set is FPA.

Other records listing Epic Medical Pte. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.

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.

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