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Hypodermic Needle-Pro Edge Safety Device

by Smiths Medical Asd, Inc. 510(k)

Active United States

510(k) K073188

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK073188 Date8 Feb 2008ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
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 Hypodermic Needle-Pro Edge Safety Device is a safety needle designed to reduce the risk of needlestick injuries during medical procedures. It features an integral needle safety mechanism engaged with a single-handed technique, ensuring secure and convenient use for clinicians.

The device is supplied sterile and is intended for single-use only. It is available in various sizes, including 25G x 1½" and 25G x 1", with color-coded safety sheaths for rapid identification. The device is regulated under FDA 510(k) clearance (K073188) and is distributed exclusively in the US.

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