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510(k) K190506

NeoForm Annuloplasty Ring by Genesee Biomedical, Inc. — Product Code KRH

K190506 is an FDA 510(k) premarket notification submitted by Genesee Biomedical, Inc. for the device "NeoForm Annuloplasty Ring". The FDA issued a decision of Substantially Equivalent on April 18, 2019. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Genesee Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2019
Date Received
March 1, 2019
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.

  • K252917 — ATLAAS (Atraumatic Left Atrial Appendage System) (AD) (May 22, 2026)
  • 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)
  • K161815 — FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band (October 12, 2016)
  • 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)

Other clearances for product code KRH

  • K261707 — MEMO 4D Curve™ Semirigid mitral annuloplasty ring (June 18, 2026)
  • K260498 — TriMemo™ SEMIRIGID ANNULOPLASTY RING (April 14, 2026)
  • 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)

FDA data resources