Bladed Trocar for Laparoscopic Surgery with Mdr CE Certificates

• Customization: Available
• Material: Plastic
• Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
• Quality Guarantee Period: 3 Years
• Group: Laparoscopic Surgery
• Transport Package: Carton
• Specification: 5mm with 100mm length
• Trademark: TK
• Origin: China
• HS Code: 9018909000
• Production Capacity: 100000

Product Description

Guangzhou TK Disposable Optical trocar
TOP3 china Manufacturer, 18years medical devices manufacturing expertise ,trustable and reliable.
Disposable Optical Trocar is used for puncturing the abdominal wall, approaching the abdominal cavity, supplying gas, and providing an access passage for surgical instruments during laparoscopic surgery. TK Optical Trocar enables an endoscope to be inserted with the trocar, the whole process of surgery is directly visable.
 

Detailed Photos

   MDR CE certificate laparoscopic disposable trocars for 3mm,5mm,10mm,12mm,15mm endoscopic surgery.

 

 

 

 

Product Parameters

 

Trocars (CT-A)
Specification
Product Code	Number of Cannula	Diameter (mm)	Working Length (mm)
T05-100-CT-A	1 pc 5mm	5	100
T10-100-CT-A	1 pc 10mm	10	100
T12-100-CT-A	1 pc 12mm	12	100
2T052-CT-A	2 pcs 5mm	5	100
2T102-CT-A	2 pcs 10mm	10	100
2T122-CT-A	2 pcs 12mm	12	100
4T52102-CT-A	2 pcs 5mm & 2 pcs 10mm	5 & 10	100
4T52122-CT-A	2 pcs 5mm & 2 pcs 12mm	5 & 12	100

 

Company Profile

Guangzhou T.K Medical, a high-tech enterprise specializing in medical devices for 18 years, has been dedicated to the research, development, and production of minimally invasive surgical instruments and novel oral care products. Operating from a modern factory spanning over 10,000+ square meters, we have assembled a team of 140+ medical industry professionals who drive our innovation and growth. Over the years, we have successfully applied for more than 700+ domestic and international patents,highlighting our strong R&D capabilities and laying a solid foundation for our long-term development. Today, our products are sold in over 40+ countries worldwide, generating an annual output value exceeding 100,000,000+ and earning widespread international recognition. In the future, Guangzhou T.K Medical will continue to embrace innovation, providing more advanced and efficient medical solutions to patients globally, and writing a new chapter in the cause of human health.

 

 

Certifications

We adhere to strict quality control processes and systems and have been granted 700+ domestic and international patents, including 400+ authorized patents,with our products leading in the industry.

FDA 510K Approval

FDA 510K Letter: K193272

Trade/Device Name: GTK Trocars

Regulation Number: 21 CFR 876.1500

Date: July 6, 2020

CE certificate

Registration No.: HD 60147623 0001


Report No.: 17025753 014


Effective Date: July 24, 2020

 

Packaging & Shipping

 

 

FAQ

Trocars

Q: Are you a factory or trading company?

A: Yes. We are a factory in China with 20 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. 

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