FDA Registration
Active
🇨🇳 China
GUANGZHOU T.K MEDICAL INSTRUMENT CO., LTD.
Reg #: 3008191256
·
FEI: 3008191256
·
Expires 2026
Products
7
Proprietary Names
7
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- GUANGZHOU T.K MEDICAL INSTRUMENT CO., LTD.
- Registration Number
- 3008191256
- FEI Number
- 3008191256
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 7, Jianye Six Road, East Zone of Guangzhou Economic and Technological Development District,, Huangpu District,
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K193272
Owner / Operator
- Firm Name
- GUANGZHOU T.K MEDICAL INSTRUMENT CO., LTD.
- Operator Number
- 10031132
- Address
- No. 7, Jianye Six Road, East Zone of Guangzhou Economic and Technological Development District, Huangpu District
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510765
- Country
- CN
- Correspondent
- Carrie Fu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2024-11-14 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 2022-06-13 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2022-06-13 |
| Ring (Wound Protector), Drape Retention, Internal | KGW | Class 2 | General, Plastic Surgery | No | 2025-11-24 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2025-01-07 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2025-01-07 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2024-07-11 |
Proprietary Names
GTK Trocars
GTK Veress Needles
Medline Pneumoperitoneum Needle
GTK Wound Protectors/Retractors
GTK Endolight Source
GTK Endoscope Camera System
GTK Vacuum Bells
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)