510(k) K102796 ยท GEX Powered Laser Surgical Instrument
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
| Applicant | AngioDynamics, Inc., Queensburgy NY, US |
| Decision | Substantially Equivalent, Dec 15, 2010 |
| Received | Sep 27, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2013 | Angiodynamics, Inc. AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling:
1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 114033 Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Kit 45CM Internal Sheath, Catalog No./REF 11402001, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Kit 65CM Internal Sheath, Catalog No./REF 11402002, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804.
Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch 45cm Kit w/Gripper and RFID T, Catalog No./REF 11403001, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch 65cm Kit w/Gripper and RFID T, Catalog No./REF 11403002, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY U Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS .018" System PROCEDURE KIT Featuring Gold-Tipped Fiber, 25 cm, VC EVLT NeverTouch-FRS 0.18 25 cm Kit, Catalog No./REF 11403003, STERILE -- AngioDynamics, Inc. 603 Queens Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 90 cm, VC EVLT NeverTouch-FRS 90cm Kit, Catalog No./REF 11403004, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804 Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NT FRS 45cm Kit w/19Ga Needle, Catalog No./REF 11403005, STERILE -- AngioDynamics, Inc. 603 Queensbury, Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NT FRS 65cm Kit w/19Ga Needle, Catalog No./REF 11403006, STERILE -- AngioDynamics, Inc. 603 Queensbury, Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, 45cm NeverTouch FRS .018 Procedure Kit, Catalog No./REF 11403012, STERILE -- AngioDynamics, Inc. 603 Quee Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, 65cm NeverTouch FRS .018 Procedure Kit, Catalog No./REF 11403013, STERILE -- AngioDynamics, Inc. 603 Quee Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Procedure Kit 45cm, Catalog No./REF 51402007, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. This i Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Procedure Kit 65cm, Catalog No./REF 51402008, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. This i Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, VenaCure NeverTouch FRS 45cm Clear Needle, Catalog No./REF 51403001, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY US Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VenaCure NeverTouch FRS 65cm Clear Needle, Catalog No./REF 51403002, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY U Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VC NT FRS 65cm Clear Non-Echo Needle, Catalog No./REF 51403005, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12 Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.