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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
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
Röntgenvägen 2 Se-171 54
Solna,  SE
Applicant Contact Jerker Åberg
Correspondent
Maquet Critical Care AB
Röntgenvägen 2 Se-171 54
Solna,  SE
Correspondent Contact Jerker Åberg
Regulation Number876.5980
Classification Product Code
PIF  
Date Received11/24/2025
Decision Date 08/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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