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Gouda Frame for Stereotactic Neurosurgery

by Neurosurgical Devices, Inc.

510(k) K852662

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 NumberK852662 Date21 Aug 1985ClearedStatusActive

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  • Withdrawn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
HAW
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Gouda Frame for Stereotactic Neurosurgery is a rigid frame designed for precise stereotactic procedures, enabling accurate positioning of surgical instruments within the brain or nervous system. It incorporates a calibrated guide mechanism to facilitate minimally invasive interventions, ensuring high-precision targeting for neurosurgical applications.

This device is supplied as a reusable medical instrument and is intended for use in operating rooms or neurosurgical suites. It requires attachment to the patient’s skull and coordination with imaging systems like CT scanners for accurate targeting. The frame is regulated under FDA 510(k) clearance (K852662) and falls under the product code HAW, with a decision of Substantially Equivalent (SESE) by the Neurology Advisory Committee.