Cleared Traditional

1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle

K192551 · Jiangsu Caina Medical Co.,Ltd · General Hospital
Aug 2020
Decision
328d
Days
Class 2
Risk

About This 510(k) Submission

K192551 is an FDA 510(k) clearance for the 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle, a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on August 10, 2020, 328 days after receiving the submission on September 17, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K192551 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2019
Decision Date August 10, 2020
Days to Decision 328 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEG — Syringe, Antistick
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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