DeviceClearance

AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE— 510(k) K100526

Substantially Equivalent

Kentec Medical, Inc.

FDA 510(k) clearance K100526 for AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE, Substantially Equivalent on 2010-04-22. Applicant: Kentec Medical, Inc.. Device class: 2.

Clearance details

Applicant
Kentec Medical, Inc.
Product code
Code FPD
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FPD

product code FPD
Death
6
Other
1
Total
7

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 →

Recalls naming K100526

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100526.

Data sourced from openFDA. This site is unofficial and independent of the FDA.