FDA 510(k)

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

K-번호: K190029 · 2019-09-26

신청자Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

결정일2019-09-26

제품 코드GCJ

자문 위원회GU

결정Substantially Equivalent

기기 요약

Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K190029. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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. The listed applicant is Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. The 510(k) number is K190029.

When did Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar receive FDA 510(k) clearance?

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 510(k) number K190029.

Who is the listed applicant for Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar?

The FDA 510(k) record lists Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

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.

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