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510(k) K201398

SINUSPRIME Dilation System by Stryker Ent — Product Code LRC

K201398 is an FDA 510(k) premarket notification submitted by Stryker Ent for the device "SINUSPRIME Dilation System". The FDA issued a decision of Substantially Equivalent on October 15, 2020. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420. Stryker Ent has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2020
Date Received
May 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ent Manual Surgical
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Stryker Ent

  • K193118 — TGS Guidewire and updated Scopis Software (February 21, 2020)
  • K193502 — TGS Universal Headrest with Mounting Arm (February 14, 2020)

Other clearances for product code LRC

  • K230258 — BB 8 Sinus Dilation Kit (May 25, 2023)
  • K212774 — VenSure LightGuide (February 4, 2022)
  • K201115 — Next Generation Balloon Dilation System (August 27, 2020)
  • K201472 — VenSure Balloon Device, VenSure Nav Balloon Device (August 26, 2020)
  • K181546 — Dillard Nasal Balloon Catheter (January 3, 2020)
  • K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter (May 3, 2019)
  • K181838 — Sinusway Dilation System (December 20, 2018)
  • K172737 — MESIRE - Balloon Sinus Dilatation System (December 12, 2017)
  • K171687 — Relieva SpinPlus Nav Balloon Sinuplasty System (September 5, 2017)
  • K161698 — Relieva UltirraNav Sinus Balloon Catheter (October 24, 2016)

FDA data resources