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Spinal Needles & Accessory

by Elfa Trading Co.

510(k) K834164

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK834164 Date13 Dec 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
FPK
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
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.

This device is classified as Tubing, Fluid Delivery and consists of spinal needles and associated accessories designed for medical use. Spinal needles are used to administer medications, fluids, or perform diagnostic procedures in the spinal canal, while the accessory components facilitate safe and precise handling during procedures such as epidurals or spinal anesthesia.

The Spinal Needles and Accessory are intended for single-use in clinical settings such as general hospitals. They are regulated under FDA 510(k) clearance (K834164) and fall under Device Class II (880.5440). Supplied sterile, these devices require proper storage to maintain sterility and are not intended for reuse. No MRI safety information is specified in the data.

Other devices from Elfa Trading Co.

  • Syringe

    Class II

Questions

AI-generated answers, 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.

  • What is the purpose of the Spinal Needles & Accessory device?

    The device consists of spinal needles and associated accessories designed for medical use to administer medications, fluids, or perform diagnostic procedures in the spinal canal, facilitating safe and precise handling during procedures such as epidurals or spinal anesthesia.

  • Are the Spinal Needles & Accessory devices reusable?

    No, these devices are intended for single-use only and are not designed to be reused after clinical procedures.

  • How are the Spinal Needles & Accessory devices supplied?

    The devices are supplied sterile and require proper storage to maintain their sterility until use in clinical settings such as general hospitals.

  • What is the regulatory classification of the Spinal Needles & Accessory?

    The device is classified under Device Class II (880.5440) and has received FDA 510(k) clearance (K834164) as substantially equivalent to predicate devices.