FDA 510K Laparoscopic Hepatectomy Bladeless Trocar with Stability Sleeve 3mm 5mm 10mm 12mm

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Guangzhou T.K Medical Instrument Co., Ltd.

VIP   Audited Supplier 4 years
Profile Certified by SGS/BV
Model B
Medical Devices
Metal, Plastic
Ethylene Oxide Sterilization
Three Years
Laparoscopic Surgery Patients
TK
Blister Box Packaging
China
9018909000
Product Description


G T.K bladeless tip trocars are safe, 100% leak-proofness, compatible to all kinds of surgical instruments.
 

 

Company Profile

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.

 

Product Description
 
G T.K Bladeless tip trocars are with special features as follows:
Universality: No need to have an adapter between 5mm and 15mm laparoscopic surgical instruments. It is compatible to all kinds of surgical instruments.
Safety: The ergonomic design of the trocar thread not only makes instruments stable but also reduces harm to skin.
Leak-proofness: The universal seal can be replaced without removing the trocar cannula, ensuring 100% leak-proofness.
Design: Pattern and color design is pleasing and comfortable to eyes.
Convenience: Low resistance valve with excellent sealing performance. Fixation cannula provides Stability.
Detailed Photos

Product Parameters
 
Trocars (B)   
Specification   
Product CodeNumber of CannulaDiameter (mm)Working Length (mm)
T03-70-BF1 pc 3mm370
T05-100-BF1 pc 5mm5100
T10-100-BF1 pc 10mm10100
T12-100-BF1 pc 12mm12100
T10-100-BF-10T1 pc 10mm10100
T12-100-BF-12T1 pc 12mm12100
T10-150-BF-10T1 pc 10mm10150
T12-150-BF-12T1 pc 12mm12150
T05-100-B31 pc 5mm5100
T10-100-B31 pc 10mm10100
T12-100-B31 pc 12mm12100
T10-100-B3-10T1 pc 10mm10100
T12-100-B3-10T1 pc 12mm12100
 
Packaging & Shipping

 

Certifications

 

FAQ

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: Do you provide free samples of GTK Trocars for clinical trial use?
A: Yes. We are proud and confident to provide free samples for real clinical testing and evaluation.
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. 

Please do not hesitate to contact me, I am always here waiting for assisting you!



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