Sterile NS System
K-Number: K170368 · 2017-09-11
ApplicantJeil Medical Corporation
Decision Date2017-09-11
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Sterile NS System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2017-09-11 under approval number K170368. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sterile NS System?
Sterile NS System is a medical device that received FDA 510(k) clearance on 2017-09-11. It is manufactured by Jeil Medical Corporation. The 510(k) number is K170368.
When was Sterile NS System approved by the FDA?
Sterile NS System received FDA 510(k) clearance on 2017-09-11, under approval number K170368.
What company makes Sterile NS System?
Sterile NS System is manufactured by Jeil Medical Corporation.
What is the FDA product code for Sterile NS System?
The FDA product code for Sterile NS System is GWO.
Other Devices by Jeil Medical Corporation
Related Devices (Code: GWO)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.