510(k) K112600 ยท GEX Powered Laser Surgical Instrument
ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
| Applicant | AngioDynamics, Inc., Queensburgy NY, US |
| Decision | Substantially Equivalent, Jan 30, 2012 |
| Received | Sep 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112600
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2019 | Angiodynamics, Inc. AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012 Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.