510(k) K171518
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