ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT

Powered Laser Surgical Instrument

ANGIODYNAMICS, INC.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics, Inc. Venacure Nevertouch Direct Procedure Kit.

Pre-market Notification Details

Device IDK112600
510k NumberK112600
Device Name:ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
ClassificationPowered Laser Surgical Instrument
Applicant ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
ContactTeri Juckett
CorrespondentTeri Juckett
ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury,  NY  12804
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-07
Decision Date2012-01-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H787114030130 K112600 000
H787114020020 K112600 000
H787114030010 K112600 000
H787114030020 K112600 000
H787114030030 K112600 000
H787114030040 K112600 000
H787114030050 K112600 000
H787114030060 K112600 000
H787114030070 K112600 000
H787114030120 K112600 000
H787114020010 K112600 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.