The following data is part of a premarket notification filed by Elucent Medical, Inc. with the FDA for Smartclip Soft Tissue Marker.
| Device ID | K180640 |
| 510k Number | K180640 |
| Device Name: | SmartClip Soft Tissue Marker |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Elucent Medical, Inc. 7480 Flying Cloud Drive, Suite 101 Eden Prairie, MN 55344 |
| Contact | Debra Kridner |
| Correspondent | Debra Kridner Elucent Medical, Inc. 7480 Flying Cloud Drive, Suite 101 Eden Prairie, MN 55344 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-12 |
| Decision Date | 2018-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851674008027 | K180640 | 000 |
| 00851674008256 | K180640 | 000 |
| 00851674008263 | K180640 | 000 |
| 00851674008270 | K180640 | 000 |
| 00851674008287 | K180640 | 000 |
| 00851674008294 | K180640 | 000 |
| 00851674008133 | K180640 | 000 |
| 00851674008140 | K180640 | 000 |
| 00851674008157 | K180640 | 000 |
| 00851674008164 | K180640 | 000 |
| 00851674008171 | K180640 | 000 |
| 00851674008188 | K180640 | 000 |
| 10851674008086 | K180640 | 000 |
| 10851674008000 | K180640 | 000 |
| 10851674008017 | K180640 | 000 |
| 10851674008024 | K180640 | 000 |
| 00851674008003 | K180640 | 000 |
| 00851674008010 | K180640 | 000 |
| 00851674008096 | K180640 | 000 |