Sterile Blunt for Single Use

by Shanghai Double Dove Industrial Co., Ltd.

510(k) K120420

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) K120420↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK120420	Date18 Oct 2012Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K120420
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.

A sterile blunt for single use is a device intended for medical procedures requiring access to vials or ampoules. It includes two models: a blunt fill needle and a blunt plastic cannula, both designed for single-use applications.

The blunt fill needle is used in conjunction with a syringe to penetrate vial or ampoule stoppers for injection purposes. The device is supplied sterile and intended for single use only. It received FDA 510(k) clearance under K120420 and is classified under product code FMI.