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510(k) K130354

MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) by Entrigue Surgical, Inc. — Product Code LYA

K130354 is an FDA 510(k) premarket notification submitted by Entrigue Surgical, Inc. for the device "MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)". The FDA issued a decision of Substantially Equivalent on May 29, 2013. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Entrigue Surgical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2013
Date Received
February 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Intranasal Septal
Device Class
Class I
Regulation Number
874.4780
Review Panel
EN
Submission Type

Other clearances by Entrigue Surgical, Inc.

  • K121351 — SINUS DILATION SYSTEM (August 29, 2012)
  • K082750 — ENTACT SEPTAL STAPLER, MODEL 610-00100 (January 6, 2009)
  • K072470 — BIOELAST 5-0 SUTURE, MODEL 500100 (November 16, 2007)

Other clearances for product code LYA

  • K243655 — TurbAlign (July 11, 2025)
  • K230142 — Epi-Stop Nasal Gel/epistaxis pack (March 22, 2023)
  • K213153 — SPIWay Endonasal Access Guide (October 27, 2021)
  • K202623 — Novapak Nasal Sinus Packing and Stent (December 8, 2020)
  • K181696 — ChitoZolve (November 30, 2018)
  • K180141 — SPIWay Endonasal Access Guide (February 16, 2018)
  • K170913 — Composite Removable Sinus Stent System (December 15, 2017)
  • K172179 — Chitogel Endoscopic Sinus Surgery Kit (October 17, 2017)
  • K153686 — SPIWay Endonasal Access Guide (January 28, 2016)
  • K141816 — HEMOPORE (October 23, 2014)

FDA data resources