The following data is part of a premarket notification filed by Cianna Medical, Inc. with the FDA for Cianna Medical Savi Scout Reflector And Savi Scout System.
| Device ID | K181007 |
| 510k Number | K181007 |
| Device Name: | Cianna Medical SAVI Scout Reflector And SAVI Scout System |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Cianna Medical, Inc. 6 Journey, Suite 125 Aliso Viejo, CA 92656 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik Cianna Medical, Inc. 6 Journey, Suite 125 Aliso Viejo, CA 92656 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-17 |
| Decision Date | 2018-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450434816 | K181007 | 000 |
| 20884450434912 | K181007 | 000 |
| 20884450434875 | K181007 | 000 |
| 10884450500351 | K181007 | 000 |
| 10884450500573 | K181007 | 000 |
| 20884450435032 | K181007 | 000 |
| 20884450530201 | K181007 | 000 |
| 20884450530218 | K181007 | 000 |
| 10884450530228 | K181007 | 000 |
| 10884450434960 | K181007 | 000 |
| 10884450434984 | K181007 | 000 |
| 20884450434769 | K181007 | 000 |
| 00884450434710 | K181007 | 000 |
| 10884450435851 | K181007 | 000 |
| 10884450435837 | K181007 | 000 |
| 10884450435011 | K181007 | 000 |
| 10884450435868 | K181007 | 000 |
| 10884450493325 | K181007 | 000 |
| 10884450493318 | K181007 | 000 |
| 20884450434790 | K181007 | 000 |
| 20884450434783 | K181007 | 000 |
| 10884450434465 | K181007 | 000 |