Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Acclarent, Inc.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories4
Latest FDA decision2026-02-19
TypeNumberDevice NameCodeDateActions
510(k) K253612 Acclarent AERA Eustachian Tube Balloon Dilation SystemPNZ2026-02-19 View
510(k) K230742 ACCLARENT AERA Eustachian Tube Dilation SystemPNZ2023-12-13 View
510(k) K231862 TruDi® Navigation System V3 (FG-2000-00)PGW2023-07-21 View
510(k) K221037 TruDi Shaver BladePGW2022-07-20 View
510(k) K201115 Next Generation Balloon Dilation SystemLRC2020-08-27 View
510(k) K201174 TruDi CurettePGW2020-08-12 View
510(k) K193453 TruDi ProbePGW2020-03-23 View
510(k) K190525 RELIEVA ULTIRRA Sinus Balloon CatheterLRC2019-05-03 View
510(k) K190532 TruDi NAV WirePGW2019-05-03 View
510(k) K183090 Relieva Tract Balloon Dilation SystemQGK2019-04-19 View
510(k) K180948 TruDi NAV Suction InstrumentsPGW2018-07-20 View
510(k) K173628 Acclarent ENT Navigation SystemPGW2018-03-10 View
510(k) K171761 ACCLARENT AERA Eustachian Tube Balloon Dilation SystemPNZ2018-01-16 View
510(k) K171687 Relieva SpinPlus Nav Balloon Sinuplasty SystemLRC2017-09-05 View
510(k) K161697 Acclarent NavWire Sinus Navigation GuidewirePGW2016-10-24 View
510(k) K161698 Relieva UltirraNav Sinus Balloon CatheterLRC2016-10-24 View
510(k) K153341 Relieva Scout Multi-Sinus Dilation SystemLRC2016-02-12 View
↑