Clickzip Needle Retractable Safety Syringe

FDA 510(k) K051694 · Medical Device Manufacturer (Thailand) , Ltd.

Substantially Equivalent

510(k) numberK051694

Submission

Device name
Clickzip Needle Retractable Safety Syringe
Applicant
Medical Device Manufacturer (Thailand) , Ltd.
Rayong, TH
Received
June 23, 2005
Decision date
December 21, 2005
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MEG – Syringe, Antistick
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5860
Specialty
General Hospital

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Questions and answers

When was Clickzip Needle Retractable Safety Syringe cleared by the FDA?

Clickzip Needle Retractable Safety Syringe (K051694) received a 510(k) decision of Substantially Equivalent on December 21, 2005, 181 days after the submission was received.

What is the product code of K051694?

The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.