Mayfield Child Disposable Skull Pin

by Ohio Medical Instrument Co., Inc.

510(k) K941558

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 10 Oct 2026

Documents

510(k) K941558↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK941558	Date6 Dec 1995Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 10 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K941558
FDA Product Code: HBL

Device Class: Class II
Regulation: 21 CFR Part 882.4460
Advisory Committee: Neurology
FDA Decision: SESE Substantially Equivalent

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