FDA.report

510(k) K173855

Device
Sharpsite AC Rigid Endsocope
Applicant
Medtronic Xomed Inc.
510(k) number
K173855
Product code
EOB  
Decision
Substantially Equivalent (SESE)
Decision date
2018-04-20
Date received
2017-12-20
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
Shravan Chawla
Address
6743 Southpoint Dr. N. Jacksonville FL US 32216 32216

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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