Home / 510(k) Clearances / K171518

510(k) K171518

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

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

Other clearances by Zhejiang Kindly Medical Devices Co., Ltd.

  • K223334 — Sterile Hypodermic Needles for Single Use (December 16, 2022)
  • K213183 — Safety Insulin Pen Needles (October 14, 2022)
  • K181069 — Disposable Insulin Pen Needle (August 28, 2018)
  • K172763 — Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle (June 4, 2018)

Other clearances for product code BSP

  • K243690 — SonoMSK (July 1, 2025)
  • K243682 — SonoPlex STIM; SonoPlex II (June 27, 2025)
  • K250774 — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (June 25, 2025)
  • K243525 — SonoTAP and SonoTAP II (March 24, 2025)
  • K241953 — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (November 22, 2024)
  • K241954 — SonoBlock; SonoBlock II (September 11, 2024)
  • K240253 — Reach Needle (March 21, 2024)
  • K212982 — Medispine - Spinal Needle, Glospine - Spinal Needle (July 29, 2022)
  • K211085 — BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (July 1, 2022)
  • K210978 — BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle (December 22, 2021)