FDA.report

510(k) K171687

Device
Relieva SpinPlus Nav Balloon Sinuplasty System
Applicant
Acclarent, Inc.
510(k) number
K171687
Product code
LRC  
Decision
Substantially Equivalent (SESE)
Decision date
2017-09-05
Date received
2017-06-07
Regulation
874.4420
Classification name
Instrument, Ent Manual Surgical
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
James Patrick Garvey II
Address
33 Technology Dr. Irvin CA US 92618 92618

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
20705031245430RELIEVA SPINPLUS NAVACCLARENT, INC.2018-02-18
20705031241012RELIEVA SPINPLUS NAVACCLARENT, INC.2018-02-18
20705031245423RELIEVA SPINPLUS NAVACCLARENT, INC.2018-02-09
20705031241005RELIEVA SPINPLUS NAVACCLARENT, INC.2018-02-09

Legacy Summary

summary

FDA Review

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