The following data is part of a premarket notification filed by Tianjin Uwell Medical Device Manufacturing Co.ltd. with the FDA for U-ignite Bladeless Trocar.
| Device ID | K162387 |
| 510k Number | K162387 |
| Device Name: | U-IGNITE Bladeless Trocar |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. A02, PLANT B, NO. 278, HANGKONG RD, TIANJIN FREE TRADE ZONE Tianjin, CN 300308 |
| Contact | Tao Fan |
| Correspondent | Tao Fan TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. A02, PLANT B, NO. 278, HANGKONG RD, TIANJIN FREE TRADE ZONE Tianjin, CN 300308 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-25 |
| Decision Date | 2017-01-11 |
| Summary: | summary |