FDA.report

510(k) K170683

Device
Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
Applicant
Aesculap, Inc.
510(k) number
K170683
Product code
GCJ  
Decision
Substantially Equivalent (SESE)
Decision date
2018-02-20
Date received
2017-03-07
Regulation
876.1500
Classification name
Laparoscope, General & Plastic Surgery
Medical specialty
Gastroenterology/Urology
Review panel
General & Plastic Surgery
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
Jessica Stigliano
Address
3773 Corporate Pkwy. Center Valley PA US 18034 18034

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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