510(k) clearance

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)

FDA 510(k) source

510(k) number

K253715

Applicant

Maquet Critical Care AB

Decision date

Aug 26, 2026

Date received

Nov 24, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

PIF

Device type

Gastrointestinal Tubes With Enteral Specific Connectors

Device class

Class II

Regulation

21 CFR 876.5980

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Solna, SE