Haskal Torque Device

by Elcam Medical ACAL 510(k)

Active United States

510(k) K100425

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK100425	Date17 Jun 2010Cleared	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Withdrawn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: K100425
FDA Product Code: DQX

Regulation: 21 CFR Part 870.1330
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

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