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510(k) K230258

BB 8 Sinus Dilation Kit by Excelent, Inc. — Product Code LRC

K230258 is an FDA 510(k) premarket notification submitted by Excelent, Inc. for the device "BB 8 Sinus Dilation Kit". The FDA issued a decision of Substantially Equivalent on May 25, 2023. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2023
Date Received
January 31, 2023
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 for product code LRC

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  • K201398 — SINUSPRIME Dilation System (October 15, 2020)
  • 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