Anesthesia Conduction Needles

FDA 510(k) K131006 · Lccs Products Limited

Substantially Equivalent

510(k) numberK131006

Submission

Device name
Anesthesia Conduction Needles
Applicant
Lccs Products Limited
Guangzhou, Guangdong, CN
Received
April 11, 2013
Decision date
December 6, 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
BSP – Needle, Conduction, Anesthetic (W/Wo Introducer)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5150
Specialty
Anesthesiology

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Questions and answers

When was Anesthesia Conduction Needles cleared by the FDA?

Anesthesia Conduction Needles (K131006) received a 510(k) decision of Substantially Equivalent on December 6, 2013, 239 days after the submission was received.

What is the product code of K131006?

The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.