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H-H Burr Hole Catheter Support

by Holter-Hausner Intl. 2 variants

510(k) K853367

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 NumberK853367 Date11 Sep 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  • Withdrawn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
GXR
Device Class
Class II
Regulation
21 CFR Part 882.5250
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The H-H Burr Hole Catheter Support is a Cover, Burr Hole device, classified under FDA regulation 882.5250. It is designed to secure and stabilize catheters inserted through burr holes in cranial surgery, ensuring proper alignment and reducing the risk of displacement during neurological procedures.

This device is intended for single-use in sterile neurosurgical settings and is regulated under FDA 510(k) clearance (K853367) with a classification as a Class II medical device. Supplied as a reusable or disposable accessory (as indicated by the product code GXR), it requires proper handling and storage to maintain sterility and functionality. No MRI safety information is specified in the data.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the H-H Burr Hole Catheter Support used for?

    The H-H Burr Hole Catheter Support is specifically designed to secure and stabilize catheters inserted through burr holes during cranial neurosurgical procedures. Its purpose is to ensure proper alignment of the catheter, minimizing the risk of displacement and maintaining stability throughout the operation.

  • Is the H-H Burr Hole Catheter Support intended for single-use or reuse?

    The H-H Burr Hole Catheter Support is intended for single-use in sterile neurosurgical settings. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical in cranial procedures.

  • How is the H-H Burr Hole Catheter Support supplied?

    The device is supplied as a reusable or disposable accessory, as indicated by its FDA product code (GXR). While the product code suggests flexibility in supply options, the intended use is for single-use in sterile environments to comply with neurosurgical best practices.

  • Does the H-H Burr Hole Catheter Support require special storage conditions?

    Since the device is intended for single-use in sterile settings, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper packaging should be maintained until use to preserve sterility and functionality.

  • Is MRI safety information provided for the H-H Burr Hole Catheter Support?

    The available data does not specify MRI safety information for the H-H Burr Hole Catheter Support. Clinicians should verify compatibility with MRI equipment and protocols before use in patients who may require postoperative imaging.