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510(k) K212774

VenSure LightGuide by Intersect Ent. — Product Code LRC

K212774 is an FDA 510(k) premarket notification submitted by Intersect Ent. for the device "VenSure LightGuide". The FDA issued a decision of Substantially Equivalent on February 4, 2022. 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
February 4, 2022
Date Received
September 1, 2021
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

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  • 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