ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

by Epic Medical Pte., Ltd.

510(k) K251340

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 25 Oct 2026

Documents

510(k) K251340↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK251340	Date29 May 2025Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K251340
FDA Product Code: ONB
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

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