U-IGNITE Bladeless Trocar
K-Number: K162387 · 2017-01-11
Decision Date2017-01-11
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
U-IGNITE Bladeless Trocar is a medical device manufactured by Tianjin Uwell Medical Device Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2017-01-11 under approval number K162387. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the U-IGNITE Bladeless Trocar?
U-IGNITE Bladeless Trocar is a medical device that received FDA 510(k) clearance on 2017-01-11. It is manufactured by Tianjin Uwell Medical Device Manufacturing Co., Ltd.. The 510(k) number is K162387.
When was U-IGNITE Bladeless Trocar approved by the FDA?
U-IGNITE Bladeless Trocar received FDA 510(k) clearance on 2017-01-11, under approval number K162387.
What company makes U-IGNITE Bladeless Trocar?
U-IGNITE Bladeless Trocar is manufactured by Tianjin Uwell Medical Device Manufacturing Co., Ltd..
What is the FDA product code for U-IGNITE Bladeless Trocar?
The FDA product code for U-IGNITE Bladeless Trocar is GCJ.
Other Devices by Tianjin Uwell Medical Device Manufacturing Co., Ltd.
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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.