Home / 510(k) Clearances / K110623

510(k) K110623

PILLAR PALATAL IMPLANT SYSTEM by Medtronic Xomed, Inc. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2012
Date Received
March 3, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

Other clearances by Medtronic Xomed, Inc.

  • K251672 — NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tu (February 10, 2026)
  • K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotrache (October 26, 2023)
  • K231580 — NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (August 30, 2023)
  • K213246 — NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, N (March 21, 2022)
  • K210841 — NuVent Eustachian Tube Dilation Balloon (August 16, 2021)
  • K202623 — Novapak Nasal Sinus Packing and Stent (December 8, 2020)
  • K200759 — NIM Vital, Nerve Integrity Monitor (October 28, 2020)
  • K173855 — Sharpsite AC Rigid Endsocope (April 20, 2018)
  • K152121 — NuVent EM Sinus Dilation System (December 1, 2015)
  • K151758 — ALAR Nasal Valve Stent (October 29, 2015)

Other clearances for product code LRK

  • K253845 — Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) (March 3, 2026)
  • K252531 — Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (March 2, 2026)
  • K252976 — Park Dental Nylon MAD (December 18, 2025)
  • K253868 — QuietLab Pro (December 5, 2025)
  • K252161 — Hushd Avera (November 25, 2025)
  • K252525 — AIO Breathe (November 6, 2025)
  • K252698 — NightGuard Aire Max (November 3, 2025)
  • K253355 — Difiney Advanced Anti Snoring Device 4.0 (October 29, 2025)
  • K251784 — Hushd Pro Z-Link (October 24, 2025)
  • K251628 — Mandibular Advancement Device L07 (October 22, 2025)