K253715

Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)

510(k) number: K253715
Device name: Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)
Applicant: Maquet Critical Care AB SE
Product code: PIF — Gastrointestinal Tubes With Enteral Specific Connect
Decision date: 2026-08-26
Date received: 2025-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K253715.pdf

Official FDA record: K253715

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.