ENFit to ENFit Extension Sets— 510(k) K230326

Name: FDA 510(k) clearance K230326
Creator: U.S. Food and Drug Administration
Published: 2023-11-02

Substantially Equivalent

Vesco Medical

FDA 510(k) clearance K230326 for ENFit to ENFit Extension Sets, Substantially Equivalent on 2023-11-02. Applicant: Vesco Medical. Device class: 2.

Clearance details

Applicant: Vesco Medical
Product code: Code PIF
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2023-02-06
Decision date: 2023-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westerville, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PIF

view all

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

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.