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Gertie Marx Needle

by Intl. Medical-Dental Products USA, Inc.

510(k) K931644

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 NumberK931644 Date22 Sep 1993ClearedStatusActive

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  • Withdrawn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
BSP
Device Class
Class II
Regulation
21 CFR Part 868.5150
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Gertie Marx Needle is a conduction needle used for anesthetic procedures. It is designed for medical and dental applications, providing a means for administering local anesthesia.

The device is supplied as a single-use or reusable product, depending on the specific model. It is regulated under FDA 510(k) clearance with product code BSP and is intended for use in anesthesiology settings. The needle is available in various sizes as specified by the manufacturer.

Questions

AI-generated answers, 23 Sep 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 Gertie Marx Needle used for?

    The Gertie Marx Needle is a conduction needle designed for anesthetic procedures, providing a means for administering local anesthesia in medical and dental applications.

  • How is the Gertie Marx Needle supplied?

    The device is supplied as a single-use or reusable product, depending on the specific model, allowing flexibility based on clinical needs and manufacturer specifications.

  • What sizes or models are available for the Gertie Marx Needle?

    The Gertie Marx Needle is available in various sizes as specified by the manufacturer, though exact dimensions are not detailed in the provided data.

  • Is the Gertie Marx Needle sterile?

    The device data does not specify sterility status; users should consult the manufacturer's labeling for each model to determine if it is supplied sterile or requires sterilization before use.

  • What regulatory pathway was used for the Gertie Marx Needle?

    The Gertie Marx Needle is regulated under FDA 510(k) clearance with product code BSP and was found substantially equivalent to a predicate device, receiving clearance on September 22, 1993.