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510(k) K161815

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band by Genesee Biomedical, Inc. — Product Code KRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2016
Date Received
July 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Annuloplasty
Device Class
Class II
Regulation Number
870.3800
Review Panel
CV
Submission Type

Other clearances by Genesee Biomedical, Inc.

  • K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (July 25, 2025)
  • K232599 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (April 9, 2024)
  • K230679 — WellsForm Tricuspid Annuloplasty Band (WF) (May 26, 2023)
  • K202253 — TruForm Sievers Annuloplasty Ring (October 6, 2020)
  • K190506 — NeoForm Annuloplasty Ring (April 18, 2019)
  • K093903 — ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC (July 15, 2010)
  • K090428 — ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC (May 7, 2009)
  • K083683 — ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC (February 25, 2009)
  • K072655 — ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR (October 23, 2007)
  • K071214 — ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING (July 31, 2007)

Other clearances for product code KRH

  • K253232 — Seguin Annuloplasty Ring (October 29, 2025)
  • K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900) (September 23, 2025)
  • K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450) (September 17, 2025)
  • K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (July 25, 2025)
  • K232599 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (April 9, 2024)
  • K230679 — WellsForm Tricuspid Annuloplasty Band (WF) (May 26, 2023)
  • K230318 — Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring (April 7, 2023)
  • K202253 — TruForm Sievers Annuloplasty Ring (October 6, 2020)
  • K201449 — SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuFo (July 1, 2020)
  • K192762 — Physio Flex Annuloplasty Ring (December 16, 2019)