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ProSeal Closed System Administration Set

by Epic Medical Pte., Ltd.

510(k) K230343

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230343 Date3 Nov 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FPA
FDA applicant
Epic Medical Pte. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A closed system administration set is a device used for the safe transfer and administration of medications, designed to prevent exposure to hazardous substances and maintain sterility during infusion processes. This device is intended for use in general hospital settings as part of closed system transfer devices for medication handling.

The ProSeal Closed System Administration Set is supplied as a single-use, sterile device and is designed for use in pharmacy and clinical environments to enhance safety during medication preparation and administration. It has received FDA 510(k) clearance (K230343) as substantially equivalent to a legally marketed device, with product code FPA and review under the General Hospital advisory committee.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ProSeal Closed System Administration Set used for?

    The ProSeal Closed System Administration Set is designed for the safe transfer and administration of medications in hospital settings. It helps prevent exposure to hazardous substances and maintains sterility during infusion processes, enhancing safety during medication preparation and administration.

  • Is the ProSeal Closed System Administration Set single-use or reusable?

    The ProSeal Closed System Administration Set is supplied as a single-use, sterile device. It is designed for one-time use to ensure maximum safety and sterility during medication handling in pharmacy and clinical environments.

  • What regulatory approvals does the ProSeal Closed System Administration Set have?

    The ProSeal Closed System Administration Set has received FDA 510(k) clearance (K230343) as substantially equivalent to a legally marketed device. It is classified under product code FPA and was reviewed under the General Hospital advisory committee.

  • How is the ProSeal Closed System Administration Set supplied?

    The ProSeal Closed System Administration Set is supplied as a sterile, single-use device ready for immediate use in pharmacy and clinical environments. It is designed to enhance safety during medication preparation and administration processes.