Home / 510(k) Clearances / K213153

510(k) K213153

SPIWay Endonasal Access Guide by Spiway, LLC — Product Code LYA

K213153 is an FDA 510(k) premarket notification submitted by Spiway, LLC for the device "SPIWay Endonasal Access Guide". The FDA issued a decision of Substantially Equivalent on October 27, 2021. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Spiway, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2021
Date Received
September 28, 2021
Clearance Type
Special
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 Spiway, LLC

  • K180141 — SPIWay Endonasal Access Guide (February 16, 2018)
  • K153686 — SPIWay Endonasal Access Guide (January 28, 2016)
  • K132721 — SPIWAY ENDONASAL ACCESS GUIDE (January 29, 2014)

Other clearances for product code LYA

  • K243655 — TurbAlign (July 11, 2025)
  • K230142 — Epi-Stop Nasal Gel/epistaxis pack (March 22, 2023)
  • 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)
  • K141704 — NOVASHIELD INJECTABLE NASAL PACKING AND STENT (October 6, 2014)

FDA data resources