Cleared Traditional

Oral/Enteral Syringe with ENFit connector

K211025 · Ningbo Tianyi Medical Appliance Co., Ltd. · Gastroenterology & Urology

Jun 2021

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K211025 is an FDA 510(k) clearance for the Oral/Enteral Syringe with ENFit connector, a Enteral Syringes With Enteral Specific Connectors (Class II — Special Controls, product code PNR), submitted by Ningbo Tianyi Medical Appliance Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on June 30, 2021, 85 days after receiving the submission on April 6, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K211025 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2021
Decision Date	June 30, 2021
Days to Decision	85 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.