SINUS DILATION SYSTEM— 510(k) K121351

Name: FDA 510(k) clearance K121351
Creator: U.S. Food and Drug Administration
Published: 2012-08-29

Substantially Equivalent

Entrigue Surgical, Inc.

FDA 510(k) clearance K121351 for SINUS DILATION SYSTEM, Substantially Equivalent on 2012-08-29. Applicant: Entrigue Surgical, Inc.. Device class: 1.

Clearance details

Applicant: Entrigue Surgical, Inc.
Product code: Code LRC
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 2012-05-04
Decision date: 2012-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRC

view all

K230258 — BB 8 Sinus Dilation Kit2023-05-25
K212774 — VenSure LightGuide2022-02-04
K201398 — SINUSPRIME Dilation System2020-10-15
K201115 — Next Generation Balloon Dilation System2020-08-27
K201472 — VenSure Balloon Device, VenSure Nav Balloon Device2020-08-26

More clearances from Entrigue Surgical, Inc.

view all

K130354 — MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)2013-05-29
K082750 — ENTACT SEPTAL STAPLER, MODEL 610-001002009-01-06
K072470 — BIOELAST 5-0 SUTURE, MODEL 5001002007-11-16

Adverse events under product code LRC

product code LRC

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.