DeviceClearance

ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT— 510(k) K112600

Substantially Equivalent

AngioDynamics, Inc.

FDA 510(k) clearance K112600 for ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT, Substantially Equivalent on 2012-01-30. Applicant: AngioDynamics, Inc.. Device class: 2.

Clearance details

Applicant
AngioDynamics, Inc.
Product code
Code GEX
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Queensburgy, NY, US
Download summary PDFView on FDA.gov ↗

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More clearances from AngioDynamics, Inc.

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Adverse events under product code GEX

product code GEX
Death
33
Injury
3,045
Malfunction
12,903
Other
25
Total
16,006

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 K112600

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 K112600.

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