FDA.report

510(k) K132433

Device
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
Applicant
ACCLARENT, INC.
510(k) number
K132433
Product code
EOB  
Decision
Substantially Equivalent (SESE)
Decision date
2014-04-24
Date received
2013-08-05
Regulation
874.4760
Classification name
Nasopharyngoscope (flexible Or Rigid)
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
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
1525-B Obrien Dr. Menlo Park CA US 94025 94025

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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