The following data is part of a premarket notification filed by Brightwater Medical with the FDA for Convertx Nephroureteral Stent System.
| Device ID | K161277 |
| 510k Number | K161277 |
| Device Name: | ConvertX Nephroureteral Stent System |
| Classification | Stent, Ureteral |
| Applicant | BRIGHTWATER MEDICAL 816 W. BENNETT CT. Dunlap, IL 61525 |
| Contact | Bob Smouse |
| Correspondent | Bob Smouse BRIGHTWATER MEDICAL 816 W. BENNETT CT. Dunlap, IL 61525 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-06 |
| Decision Date | 2016-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851571007536 | K161277 | 000 |
| 10884450453121 | K161277 | 000 |
| 10884450453107 | K161277 | 000 |
| 10884450453077 | K161277 | 000 |
| 10884450453039 | K161277 | 000 |
| 10884450452865 | K161277 | 000 |
| 10884450453152 | K161277 | 000 |
| 10884450452858 | K161277 | 000 |
| 10884450453145 | K161277 | 000 |
| 10884450453091 | K161277 | 000 |
| 10884450452872 | K161277 | 000 |
| 10884450458560 | K161277 | 000 |
| 20884450458604 | K161277 | 000 |
| 20884450458543 | K161277 | 000 |
| 10884450458584 | K161277 | 000 |
| 10884450458522 | K161277 | 000 |
| 10884450458508 | K161277 | 000 |
| 10884450458485 | K161277 | 000 |
| 10884450453169 | K161277 | 000 |
| 10884450453176 | K161277 | 000 |
| 00851571007529 | K161277 | 000 |
| 00851571007512 | K161277 | 000 |
| 00851571007505 | K161277 | 000 |
| 00851571007499 | K161277 | 000 |
| 00851571007482 | K161277 | 000 |
| 00851571007383 | K161277 | 000 |
| 00851571007376 | K161277 | 000 |
| 00851571007369 | K161277 | 000 |
| 00851571007352 | K161277 | 000 |
| 00851571007345 | K161277 | 000 |
| 00851571007284 | K161277 | 000 |
| 00851571007260 | K161277 | 000 |
| 00851571007246 | K161277 | 000 |
| 00851571007222 | K161277 | 000 |
| 00851571007208 | K161277 | 000 |
| 10884450453190 | K161277 | 000 |
| 10884450453183 | K161277 | 000 |
| 10884450458461 | K161277 | 000 |