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510(k) K980221

SILIMED NASAL RETAINER by Silimed, LLC — Product Code LYA

K980221 is an FDA 510(k) premarket notification submitted by Silimed, LLC for the device "SILIMED NASAL RETAINER". The FDA issued a decision of Substantially Equivalent on April 2, 1998. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Silimed, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1998
Date Received
January 22, 1998
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 Silimed, LLC

  • K042054 — SILIMED PECTORAL IMPLANT (February 23, 2005)
  • K974479 — SILIMED VAGINAL STENT (August 5, 1998)
  • K981852 — SILIMED TISSUE EXPANDER (August 5, 1998)
  • K981850 — SILIMED CHIN IMPLANTS (July 9, 1998)
  • K981835 — SILIMED MALAR IMPLANT (July 9, 1998)
  • K981851 — SILIMED SILICONE CARVING BLOCK (July 9, 1998)
  • K981833 — SILIMED NASAL L SHAPED IMPLANT (June 26, 1998)
  • K974482 — SILIMED GLUTEAL IMPLANT (February 24, 1998)
  • K974480 — SILIMED CALF IMPLANT (February 24, 1998)

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