510(k) K171518

Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles by Zhejiang Kindly Medical Devices Co., Ltd. — Product Code BSP

K171518 is an FDA 510(k) premarket notification submitted by Zhejiang Kindly Medical Devices Co., Ltd. for the device "Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles". The FDA issued a decision of Substantially Equivalent on January 5, 2018. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Zhejiang Kindly Medical Devices Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2018
Date Received
May 24, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type