Terumo Needle With Locking Sheath

by Terumo Medical Corp.

510(k) K000387

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

510(k) K000387↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Abbreviated	NumberK000387	Date2 Mar 2000Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K000387

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K000387
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, 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.

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an.

The device is identified by the model number K000387 and was cleared through the FDA 510(k) process as substantially equivalent. It is manufactured by Terumo Medical Corp. and authorized under product code FMI.