U-IGNITE Bladeless Trocar
K-Number: K162387 · 2017-01-11
Device Summary
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. The listed applicant is Tianjin Uwell Medical Device Manufacturing Co., Ltd.. The 510(k) number is K162387.
When did U-IGNITE Bladeless Trocar receive FDA 510(k) clearance?
U-IGNITE Bladeless Trocar received FDA 510(k) clearance on 2017-01-11, under 510(k) number K162387.
Who is the listed applicant for U-IGNITE Bladeless Trocar?
The FDA 510(k) record lists Tianjin Uwell Medical Device Manufacturing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for U-IGNITE Bladeless Trocar?
The FDA product code for U-IGNITE Bladeless Trocar is GCJ.
Other records listing Tianjin Uwell Medical Device Manufacturing Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GCJ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.