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Hemedex Cranial Bolt Models 3601 3602

by Hemedex Incorporated

510(k) K032337

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

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032337 Date21 Oct 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GWM
Device Class
Class II
Regulation
21 CFR Part 882.1620
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Hemedex Cranial Bolt Models 3601 and 3602 are stainless steel threaded cranial access devices. They are designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring.

The device is supplied as a stainless steel threaded cranial access device with standard tuohy borst compression fittings. It is intended for use in intracranial monitoring. The device is not described as single-use or reusable, and no information on sterility, storage, or MRI safety is provided.

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