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 | K161507 |
| 510k Number | K161507 |
| Device Name: | Cianna Medical SAVI Scout Reflector And SAVI Scout System |
| Classification | Internal Tissue Marker |
| 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 | PDW |
| CFR Regulation Number | 878.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2016-07-29 |