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510(k) K201356

Plastic LOR Syringe by Jiangsu Caina Medical Co.,Ltd — Product Code CAZ

K201356 is an FDA 510(k) premarket notification submitted by Jiangsu Caina Medical Co.,Ltd for the device "Plastic LOR Syringe". The FDA issued a decision of Substantially Equivalent on February 12, 2021. The device falls under product code CAZ (Anesthesia Conduction Kit), a Class II device regulated under 21 CFR 868.5140. Jiangsu Caina Medical Co.,Ltd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2021
Date Received
May 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anesthesia Conduction Kit
Device Class
Class II
Regulation Number
868.5140
Review Panel
AN
Submission Type

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Jiangsu Caina Medical Co.,Ltd

  • K232781 — Safety Sliding Blood Collection Set (March 7, 2024)
  • K233190 — ENFit Adaptor (January 18, 2024)
  • K230635 — Pen Needle (June 2, 2023)
  • K220184 — Pump Alignment Syringe (July 21, 2022)
  • K211593 — Enteral Pump Syringe (September 30, 2021)
  • K210217 — Needleless Connector (May 17, 2021)
  • K200463 — Huber Needle Infusion Set, Safety Huber Needle Infusion Set (April 7, 2021)
  • K200027 — Blood Collection Needle with/without Holder, Safety Blood Collection Needle with (September 9, 2020)
  • K193022 — Retractable Safety Insulin Syringe (July 20, 2020)
  • K193526 — Syringe with safety needle, Safety needle (July 17, 2020)

Other clearances for product code CAZ

  • K222341 — Arrow 0.2 Micron Flat Filter, GVS (February 13, 2023)
  • K210983 — BD Epilor Syringe (May 19, 2022)
  • K202699 — E-Cath STIM acc. Tsui (December 29, 2020)
  • K190345 — VPC (May 16, 2019)
  • K161075 — Arrow Epidural Catheter Kit (October 4, 2016)
  • K153652 — ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (June 21, 2016)
  • K143581 — Arrow Epidural Catheter Kit (June 26, 2015)
  • K122690 — ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE (December 21, 2012)
  • K110053 — CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRIN (September 14, 2012)
  • K122027 — ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER (August 28, 2012)

FDA data resources