The following data is part of a premarket notification filed by Well Lead Medical Co. Ltd with the FDA for Well Lead Ureteral Access Sheath.
| Device ID | K151084 |
| 510k Number | K151084 |
| Device Name: | Well Lead Ureteral Access Sheath |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | WELL LEAD MEDICAL CO. LTD C-4 JINHU INDUSTRIAL ESTATE HUALONG, PANYU Guangzhou, CN 511434 |
| Contact | Huang Kai Gen |
| Correspondent | Huang Kai Gen WELL LEAD MEDICAL CO. LTD C-4 JINHU INDUSTRIAL ESTATE HUALONG, PANYU Guangzhou, CN 511434 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-22 |
| Decision Date | 2016-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16944932787688 | K151084 | 000 |
| 16936881134248 | K151084 | 000 |
| 16936881134255 | K151084 | 000 |
| 16936881134286 | K151084 | 000 |
| 16936881134293 | K151084 | 000 |
| 16936881134309 | K151084 | 000 |
| 16936881134316 | K151084 | 000 |
| 16936881134330 | K151084 | 000 |
| 16936881134347 | K151084 | 000 |
| 16936881134354 | K151084 | 000 |
| 16936881134361 | K151084 | 000 |
| 16936881134378 | K151084 | 000 |
| 16936881134392 | K151084 | 000 |
| 16936881134408 | K151084 | 000 |
| 16944932787657 | K151084 | 000 |
| 16944932787664 | K151084 | 000 |
| 16944932787671 | K151084 | 000 |
| 16936881134231 | K151084 | 000 |