Cleared Traditional

Plastic LOR Syringe

K201356 · Jiangsu Caina Medical Co.,Ltd · Anesthesiology

Feb 2021

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K201356 is an FDA 510(k) clearance for the Plastic LOR Syringe, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on February 12, 2021, 267 days after receiving the submission on May 21, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K201356 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 2020
Decision Date	February 12, 2021
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CAZ — Anesthesia Conduction Kit
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5140
Definition	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.