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510(k) K141816

HEMOPORE by Polyganics B.V., — Product Code LYA

K141816 is an FDA 510(k) premarket notification submitted by Polyganics B.V., for the device "HEMOPORE". The FDA issued a decision of Substantially Equivalent on October 23, 2014. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Polyganics B.V., has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2014
Date Received
July 7, 2014
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 Polyganics B.V.,

  • K141423 — NASOPORE-FD (August 7, 2014)
  • K112267 — NEUROLAC(R) NERVE GUIDE (October 20, 2011)
  • K070715 — NASOPORE EAR (May 7, 2007)
  • K062540 — NASOPORE EAR, MODELS ND04, ND05 (October 18, 2006)
  • K052099 — NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ (November 21, 2005)
  • K050573 — NEUROLAC NERVE GUIDE (May 4, 2005)
  • K042811 — VIVOSORB SHEET, MODEL FS01 (November 8, 2004)
  • K032115 — NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 (October 10, 2003)

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

FDA data resources