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510(k) K243655

TurbAlign by Spirair, Inc. — Product Code LYA

K243655 is an FDA 510(k) premarket notification submitted by Spirair, Inc. for the device "TurbAlign". The FDA issued a decision of Substantially Equivalent on July 11, 2025. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Spirair, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2025
Date Received
November 26, 2024
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 Spirair, Inc.

  • K251790 — SeptAlign (January 16, 2026)
  • K233569 — SeptAlign (March 22, 2024)
  • K223167 — Spirair Nasal Septal Strap (August 17, 2023)

Other clearances for product code LYA

  • 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)
  • K141704 — NOVASHIELD INJECTABLE NASAL PACKING AND STENT (October 6, 2014)

FDA data resources