Cleared Traditional

Disposable Enteral Feeding Sets

K240052 · Beijing L&Z Medical Technology Development Co., Ltd. · Gastroenterology & Urology

Jul 2024

Decision

177d

Days

Class 2

Risk

About This 510(k) Submission

K240052 is an FDA 510(k) clearance for the Disposable Enteral Feeding Sets, a Gastrointestinal Tubes With Enteral Specific Connectors (Class II — Special Controls, product code PIF), submitted by Beijing L&Z Medical Technology Development Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on July 3, 2024, 177 days after receiving the submission on January 8, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K240052 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 08, 2024
Decision Date	July 03, 2024
Days to Decision	177 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PIF — Gastrointestinal Tubes With Enteral Specific Connectors
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5980
Definition	To Facilitate Enteral Specific Connections.