The following data is part of a premarket notification filed by Guangzhou Tk Medical Instrument Co., Ltd. with the FDA for Gtk Trocars.
| Device ID | K193272 |
| 510k Number | K193272 |
| Device Name: | GTK Trocars |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Guangzhou TK Medical Instrument Co., Ltd. A601, Guangzhou International Business Incubator, Guangzhou Science Park Guangzhou, CN 510663 |
| Contact | Tracy Weng |
| Correspondent | Elly Xu Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road , Nanshan District Shenzhen, CN 518000 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-26 |
| Decision Date | 2020-07-09 |