Skip to content

Genesis Spray Tip Atomizer

by Mai 510(k)

Active United States

510(k) K923183

Overview

The Genesis Spray Tip Atomizer is a Class 2 syringe, piston device designed for atomization in general hospital settings. It is a medical device that utilizes a spray tip mechanism for application purposes.

The device is supplied by Mai and received FDA 510(k) clearance on July 13, 1993, with the product code FMF. It is regulated under number 880.5860 and was reviewed by the General Hospital advisory committee. No information regarding sterility, single-use status, MRI safety, or sizes is provided in the data.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923183 Date13 Jul 1993ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Genesis Spray Tip Atomizer used for?

    The Genesis Spray Tip Atomizer is a Class 2 syringe, piston device designed for atomization in general hospital settings. It utilizes a spray tip mechanism for application purposes in medical environments.

  • How is the Genesis Spray Tip Atomizer supplied?

    The device is supplied by Mai, a medical device manufacturer. The specific packaging or quantity per package is not detailed in the available information.

  • What is the regulatory status of the Genesis Spray Tip Atomizer?

    The Genesis Spray Tip Atomizer received FDA 510(k) clearance on July 13, 1993, with product code FMF. It is regulated under number 880.5860 and was reviewed by the General Hospital advisory committee.

  • Is the Genesis Spray Tip Atomizer sterile or single-use?

    No information regarding sterility or single-use status is provided in the available device data. The device's specific handling instructions regarding reuse or sterilization are not detailed in the documentation.