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Needles (Hypodermic)

by Impex Laboratories

510(k) K822534

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 NumberK822534 Date17 Sep 1982ClearedStatusActive

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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
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 Needles (Hypodermic) are a type of medical device used for injecting or withdrawing fluids from the body. They are classified as a Syringe, Piston, and are used in general hospital settings. The device is substantially equivalent to other devices on the market. The product code for this device is FMF.

The Needles (Hypodermic) are supplied by Impex Laboratories and have been assigned the K number K822534. The device has a clearance type of Traditional and is classified as a Class 2 device. The device is regulated under the code 880.5860 and has been found to be substantially equivalent, with a decision date of 1982-09-17.

Other devices from Impex Laboratories

Questions

AI-generated answers, 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.

  • What are Hypodermic Needles used for?

    Hypodermic Needles are used for injecting or withdrawing fluids from the body in general hospital settings.

  • How are the Needles supplied?

    The Needles are supplied by Impex Laboratories, with a product code of FMF and a K number of K822534.

  • What is the regulatory classification of the device?

    The device is classified as a Class 2 device, regulated under the code 880.5860, and has been found to be substantially equivalent.