Flexi-Q Dv and Dvr Auto-Injectors

by Elcam Medical ACAL 510(k)

Active United States

510(k) K111467

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK111467	Date9 Feb 2012Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number: K111467
FDA Product Code: KZH

Device Class: Class II
Regulation: 21 CFR Part 880.6920
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

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