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10mm Disposable Optical Trocar Bladeless Trocar FDA 510K Cleared

Hebei Zhouwo Trading Co., Ltd.
  • Material：Plastic
  • Ethylene Oxide Sterilization：Ethylene Oxide Sterilization
  • Trademark：TK
  • Origin：China

Base Info

  • Model NO.：T10-100-CT-F
  • HS Code：9018909000
  • Production Capacity：100000

Description

Features and advantagesVisibleAn endoscope can be inserted into an optical trocar to make the whole surgery process visible.SafetyThe ergonomic design of the trocar thread not only makes instruments stable but also reduces harm to skin.UniversalityNo need to have an adapter between 5mm and 12mm instruments. It is compatible to all kinds of surgical instruments.Leak-proofness:The universal seal can be replaced without removing the trocar cannula, ensuring 100% leak-proofness.Pleasing DesignPattern and color design is pleasing and comfortable to eyes.DetachabilityThe sealing components can be detached to remove large tissue or organ.Reliability21 inspection steps on each trocar ensures high quality.

We have specialized in medical devices and laparoscopic instruments field for over 17 years. Our products have been sold to more than 1000 top-rank hospitals in China. Our annual sales volume for trocars and retriever bags exceeds 100,000 units.

We export trocars, retriever bags and veress needles to 40 countries, most of which are European and American countries, such as the USA, UK, France, Germany, Italy, Belgium, Spain, Japan, South Korea.

We offer full range and high-quality products--We were on-site audited by FDA from 1/3/2015 to 1/13/2015, and from 7/5/2021 to 16/5/2021. We passed FDA audit and have established stable contact relationship with FDA auditors.

We have FDA Registration, CE Certificate, ISO13485:2016 Certificate, Free Sale Certificate, and Declaration of Conformity for all our products including retriever bags, trocars, veress needles.

10mm Disposable Optical Trocar Bladeless Trocar FDA 510K Cleared
10mm Disposable Optical Trocar Bladeless Trocar FDA 510K Cleared10mm Disposable Optical Trocar Bladeless Trocar FDA 510K Cleared
10mm Disposable Optical Trocar Bladeless Trocar FDA 510K Cleared

10mm Disposable Optical Trocar Bladeless Trocar FDA 510K Cleared

Q: Are you a factory or trading company?
A: Yes. We are a factory in China with 17 years surgical devices developing and manufacturing experience.
Q: What is the core strength of GTK Medical?
A: Our core strength is strong R&D Capability (more than 600 patents applied) and world first class quality (FDA 510K, CE, ISO13485:2016) management on products.
Q: What makes GTK Trocars stand out?
A:  Excellent sealing performance plus excellent smooth insertion and removal of surgical instruments.
Q: Is OEM or ODM available?
A: Yes. OEM or ODM is available based on customer's certain order quantity.
Q: Do you have exported experiences to large medical devices company/companies?
A: Yes. We exported to more than 40 countries, most of which are based in the America and Europe.
Q: Do you accept factory audit prior to formal partnership?
A: Yes. We are proud and confident to accept factory audit. We passed US FDA on site aduits on 2015 and 2021. 

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