Data / Medical devices / China / Guangzhou T.K Medical Instrument Co., Ltd.
Guangzhou T.K Medical Instrument Co., Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 2 510(k) clearances
Guangzhou T.K Medical Instrument Co., Ltd. is registered with the FDA (registration 3008191256) in Guangzhou Guangdong, China. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 9, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008191256
- Address
- No. 7, Jianye Six Road, East Zone of Guangzhou Economic and Technological Development District, Huangpu District, Guangzhou Guangdong, China, 510765
- Owner or operator
- GUANGZHOU T.K MEDICAL INSTRUMENT CO., LTD. (10031132)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 13, 2012
- Registered through
- 2027
- Brand names listed
- GTK Endolight Source, GTK Endoscope Camera System, GTK Trocars, GTK Vacuum Bells, GTK Veress Needles, GTK Wound Protectors/Retractors, Medline Pneumoperitoneum Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Television, Endoscopic, Without Audio | FWF | 1 | Manufacturer | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Thoracic | IPT | 1 | Manufacturer | accessdata.fda.gov |
| Pneumoperitoneum Needle | FHO | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Ring (Wound Protector), Drape Retention, Internal | KGW | 2 | Manufacturer | accessdata.fda.gov |
| Source, Carrier, Fiberoptic Light | EQH | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 9, 2020 | K193272 | GTK Trocars | GCJ | Substantially Equivalent | Guangzhou T.K Medical Instrument Co., Ltd. | accessdata.fda.gov |
| January 30, 2020 | K193339 | GTK Veress Needles | HIF | Substantially Equivalent | Guangzhou T.K Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Thoracic
- All makers of Camera, Television, Endoscopic, Without Audio
- All makers of Ring (Wound Protector), Drape Retention, Internal
- All makers of Pneumoperitoneum Needle
- All makers of Insufflator, Laparoscopic
- All makers of Laparoscope, General & Plastic Surgery
Updated July 9, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.