Cleared Traditional

Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector

K222155 · Jiangsu Caina Medical Co.,Ltd · Gastroenterology & Urology

Sep 2022

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K222155 is an FDA 510(k) clearance for the Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector, a Enteral Syringes With Enteral Specific Connectors (Class II — Special Controls, product code PNR), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on September 16, 2022, 58 days after receiving the submission on July 20, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K222155 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 20, 2022
Decision Date	September 16, 2022
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PNR — Enteral Syringes With Enteral Specific Connectors
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5980
Definition	Delivers Nutrition, Medication, Or Hydration Orally Or To A Gastrointestinal Tube Or Extension Set Using Aami/cn3(ps):2014 Compliant Connectors.