ClearanceBrief
510(k) K094021 ยท NEY System, Ablation, Microwave And Accessories

ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I

ApplicantMicrosulis Medical Limited, Denmead Hampshire, GB
DecisionSubstantially Equivalent, Aug 6, 2010
ReceivedDec 30, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K094021

DateFirm and productCodeLinked 510(k)
Jun 5, 2017Angiodynamics, Inc.
Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMT
Terminated		 NEYNone listed
Jun 5, 2017Angiodynamics, Inc.
Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA M
Terminated		 NEYNone listed
Jun 5, 2017Angiodynamics, Inc.
Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i
Terminated		 NEYNone listed
Jun 5, 2017Angiodynamics, Inc.
Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu
Terminated		 NEYNone listed
Jun 5, 2017Angiodynamics, Inc.
Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pM
Terminated		 NEYNone listed
Jun 5, 2017Angiodynamics, Inc.
Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis A
Terminated		 NEYNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.