Cleared Traditional

Oral/Enteral Syringe with ENFit connector

K222772 · Anhui Tiankang Medical Technology Co., Ltd. · Gastroenterology & Urology

Aug 2023

Decision

337d

Days

Class 2

Risk

About This 510(k) Submission

K222772 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 Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on August 17, 2023, 337 days after receiving the submission on September 14, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K222772 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2022
Decision Date	August 17, 2023
Days to Decision	337 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.