Disposable Enteral Feeding Sets— 510(k) K240052

Name: FDA 510(k) clearance K240052
Creator: U.S. Food and Drug Administration
Published: 2024-07-03

Substantially Equivalent

Beijing L&Z Medical Technology Development Co., Ltd.

FDA 510(k) clearance K240052 for Disposable Enteral Feeding Sets, Substantially Equivalent on 2024-07-03. Applicant: Beijing L&Z Medical Technology Development Co., Ltd.. Device class: 2.

Clearance details

Applicant: Beijing L&Z Medical Technology Development Co., Ltd.
Product code: Code PIF
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2024-01-08
Decision date: 2024-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code PIF

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K260110 — danumed Extension Set for Gastrostomy Button2026-09-10
K253715 — Edi Catheter ENFit 6Fr/48 cm (6893166) +7 more2026-08-26
K254170 — Percutaneous Endoscopic Gastrostomy (PEG) Kit2026-03-20
K242917 — Enteral Drainage System, Enteral Medicine straw2025-06-18
K250481 — Extension Feeding Set with ENFit Connectors2025-04-18

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Adverse events under product code PIF

product code PIF

Death: 13
Injury: 122
Other: 1
Total: 136

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.