Acrodisc Filter Assembly

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K802765 ↗

FDA Product Code

FPB

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Gelman Sciences, Inc. →

• What is the Acrodisc Filter Assembly used for?

  The Acrodisc Filter Assembly is used in filtration applications in general hospital settings.

• Is the Acrodisc Filter Assembly supplied sterile?

  The description does not specify if the device is supplied sterile, but it is intended for use in filtration applications.

• What is the regulatory classification of the Acrodisc Filter Assembly?

  The device is classified as a class 2 device and is regulated under the regulation number 880.5440.

• What is the FDA clearance status of the Acrodisc Filter Assembly?

  The device has been cleared by the FDA with the k number K802765.