DeviceClearance

Edi Catheter ENFit 6Fr/48 cm (6893166) +7 more— 510(k) K253715

Substantially Equivalent

Maquet Critical Care AB

FDA 510(k) clearance K253715 for Edi Catheter ENFit 6Fr/48 cm (6893166) +7 more, Substantially Equivalent on 2026-08-26. Applicant: Maquet Critical Care AB. Device class: 2.

Summary

Maquet Critical Care's submission lists eight Edi Catheter ENFit sizes, from 6Fr/48 cm (6893166) up to 16Fr/125cm (6893279). They're filed under product code PIF, gastrointestinal tubes with enteral specific connectors.

Class II, 21 CFR 876.5980. Gastroenterology and Urology is both the classification panel and the review panel, and it was a Traditional 510(k).

Maquet filed from Solna, Sweden. The substantially equivalent decision came 275 calendar days after receipt (November 24, 2025 to August 26, 2026).

Clearance details

Device name as filed
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
Product code
Product code PIF
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Solna, SE
Download summary PDFView on FDA.gov ↗

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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, through . 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.