HandX

by Human Xtensions, Ltd.

510(k) K212214

HandX is a Class II device made by Human Xtensions, Ltd., cleared under FDA 510(k) K212214 on 13 Sep 2021, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K212214↗

FDA record

Trust

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK212214	Date13 Sep 2021Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K212214

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K212214
FDA product code: GCJ
FDA applicant: Human Xtensions , Ltd.

Device class: Class II
Regulation: 21 CFR Part 876.1500
Advisory committee: Gastroenterology, Urology
FDA decision: SESE Substantially Equivalent

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See all devices from Human Xtensions, Ltd. →