510(k) K242732

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

May 9, 2025

Date Received

September 10, 2024

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Foam Or Gel Chemical Sterilant/High Level Disinfectant

Device Class

Class II

Regulation Number

880.6886

Review Panel

HO

Submission Type

A foam or gel chemical sterilant/high level disinfectant is a germicide in the form of a foam or gel that is intended for use as the terminal step in high level disinfection of medical devices prior to patient use.