DeviceClearance

SureFlo EVD Catheter— 510(k) K170599

Substantially Equivalent

Arkis Biosciences, Inc.

FDA 510(k) clearance K170599 for SureFlo EVD Catheter, Substantially Equivalent on 2017-08-31. Applicant: Arkis Biosciences, Inc.. Device class: 2.

Clearance details

Applicant
Arkis Biosciences, Inc.
Product code
Code JXG
Device class
Class 2
Regulation
21 CFR 882.5550
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Knoxville, TN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code JXG

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Adverse events under product code JXG

product code JXG
Death
76
Injury
5,632
Malfunction
2,230
Other
4
Total
7,942

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 K170599

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 K170599.

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