Disposable Bladeless Optical Trocar Laparoscopy Visible Entry with FDA 510K Cleared CE & ISO 13485 Certificate

• Customization: Available
• Material: Plastic
• Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
• Model NO.: T12-100-CT-F
• Quality Guarantee Period: 3 Years
• Group: Laparoscopic Surgery
• Specification: 10mm with 100mm length
• Trademark: TK
• Origin: China
• HS Code: 9018909000
• Production Capacity: 100000

Product Description

G T.K trocars have been exported to 40 countries, most of which are European and American countries, such as the USA, UK, France, Germany, Italy, Belgium, Spain, Japan, South Korea.
  

Detailed Photos

GTK disposable optical trocars Characteristic

Visible	An endoscope can be inserted into an optical trocar to make the whole surgery process visible.
Safety	The ergonomic design of the trocar thread not only makes instruments stable but also reduces harm to skin.
Universality	No 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 Design	Pattern and color design is pleasing and comfortable to eyes.
Detachability	The sealing components can be detached to remove large tissue or organ.
Reliability	21 inspection steps on each trocar ensures high quality.

 

Product Parameters

 

Specification of Trocars (Model CT)
Product Code	Number of Cannula	Diameter (mm)	Working Length (mm)
T03-55-CT-S	1 pc 3mm	3	55
T05-55-CT-S	1 pc 5mm	5	55
T05-100-CT-S	1 pc 5mm	5	100
T05-75-CT-F	1 pc 5mm	5	75
T12-75-CT-F	1 pc 12mm	12	75
T05-100-CT-F	1 pc 5mm	5	100
T10-100-CT-F	1 pc 10mm	10	100
T12-100-CT-F	1 pc 12mm	12	100
T05-150-CT-F	1 pc 5mm	5	150
T10-150-CT-F	1 pc 10mm	10	150
T12-150-CT-F	1 pc 12mm	12	150
2T052-CT-F	2 pcs 5mm	5	100
2T102-CT-F	2 pcs 10mm	10	100
2T122-CT-F	2 pcs 12mm	12	100
3T52101-CT-F	2 pcs 5mm & 1 pc 10mm	5 & 10	100
4T52102-CT-F	2 pcs 5mm & 2 pcs 10mm	5 & 10	100
4T52122-CT-F	2 pcs 5mm & 2 pcs 12mm	5 & 12	100

 

Company Profile

Guangzhou T.K Medical Instrument Co., Ltd.is a hi-tech company which focuses on the research, development, manufacturing and marketing of medical devices. 


G T.K trocars have been exported to 40 countries, most of which are European and American countries, such as the USA, UK, France, Germany, Italy, Belgium, Spain, Japan, South Korea.

 

Packaging & Shipping

 

 

Certifications

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

 

FAQ

Trocars

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. 

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