FDA 510(k)

ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT

K-Number: K070378 · 2007-03-09

Decision Date2007-03-09

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2007-03-09 under 510(k) number K070378. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT?

ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 2007-03-09. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K070378.

When did ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT receive FDA 510(k) clearance?

ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT received FDA 510(k) clearance on 2007-03-09, under 510(k) number K070378.

Who is the listed applicant for ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT?

The FDA 510(k) record lists AngioDynamics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT?

The FDA product code for ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing AngioDynamics, Inc. as applicant

K252509AlphaVac Multipurpose Mechanical Aspiration System F1885 K253106AngioVac Cannula K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)K240397AlphaVac MMA F1885 System (H787253020)K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits K223581Solero Microwave Tissue Ablation (MTA) System and Accessories

View all 82 devices →

Related Devices (Code: GEX)

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.