Cliq DV-300 Aspirator

FDA 510(k) K132308 · Ding Hwa Co., Ltd.

Substantially Equivalent

510(k) numberK132308

Submission

Device name
Cliq DV-300 Aspirator
Applicant
Ding Hwa Co., Ltd.
Buffalo, NY, US
Received
July 25, 2013
Decision date
December 30, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

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K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…JCX · Traditional Stryker Instruments12/09/2022SE
K182950Acare Suction UnitJCX · Traditional Acare Technology Co., Ltd.08/23/2019SE
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More from Taiwan Biomaterial Co., Ltd.

510(k)DeviceDecision
K181398DV-300 AspiratorJCX · Traditional 07/23/2018SE
K140809Cliq DV-300 AspiratorJCX · Traditional 06/23/2014SE
K140031Suction PumpJCX · Traditional 04/28/2014SE
K080005Sparmax Aspirator, Models TC-2000V ND VC-701JCX · Traditional 04/24/2008SE

Questions and answers

When was Cliq DV-300 Aspirator cleared by the FDA?

Cliq DV-300 Aspirator (K132308) received a 510(k) decision of Substantially Equivalent on December 30, 2013, 158 days after the submission was received.

What is the product code of K132308?

The FDA product code is JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 878.4780.