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FDA 510(k)

Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar

K-Number: K190029 · 2019-09-26

ApplicantChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd
Decision Date2019-09-26
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar is a medical device manufactured by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. It received FDA 510(k) clearance on 2019-09-26 under approval number K190029. 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 Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar?

Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar is a medical device that received FDA 510(k) clearance on 2019-09-26. It is manufactured by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. The 510(k) number is K190029.

When was Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar approved by the FDA?

Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar received FDA 510(k) clearance on 2019-09-26, under approval number K190029.

What company makes Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar?

Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar is manufactured by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd.

What is the FDA product code for Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar?

The FDA product code for Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar is GCJ.

Related Clinical Trials

NCT05110183 Opto-electrical Cochlear Implants ENROLLING_BY_INVITATION

Other Devices by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

K161905Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge K250389XNY Disposable Gastric Calibration Tube

Related Devices (Code: GCJ)

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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.

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