Cianna Medical SAVI Scout Reflector and SAVI Scout System
FDA 510(k) K171767 · Cianna Medical, Inc.
510(k) numberK171767
Submission
- Device name
- Cianna Medical SAVI Scout Reflector and SAVI Scout System
- Applicant
- Cianna Medical, Inc.
Aliso Viejo, CA, US - Received
- June 14, 2017
- Decision date
- October 31, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001)NEU · Traditional | Breast-Med, Inc. | 12/12/2025SE |
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| K243642 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | Bard Peripheral Vascular, Inc. | 03/24/2025SE |
| K233639 | SmartClip Secure Soft Tissue MarkerNEU · Traditional | Elucent Medical, Inc. | 12/20/2024SE |
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| K234149 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/26/2024SE |
| K240042 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/25/2024SE |
More from Molli Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout SystemNEU · Traditional | 08/02/2018SE |
| K161507 | Cianna Medical SAVI Scout Reflector and SAVI Scout SystemPDW · Traditional | 07/29/2016SE |
| K141318 | Cianna Medical SGS SystemPDW · Traditional | 08/27/2014SE |
| K132463 | Cianna Medical Permanent Tissue Marker and Delivery SystemNEU · Traditional | 12/03/2013SE |
| K120804 | Cianna Medical Tissue Marker and Delivery SystemPBY · Traditional | 02/04/2013SE |
| K103215 | Cianna S1, Single Lumen Balloon Applicator KitJAQ · Traditional | 11/15/2010SE |
| K101411 | Savi Preparation DeviceJAQ · Traditional | 07/12/2010SE |
| K081677 | Savi Applicator KitJAQ · Special | 07/22/2008SESU |
| K080565 | Modification to: Savi Applicator KitJAQ · Special | 04/04/2008SESU |
Questions and answers
When was Cianna Medical SAVI Scout Reflector and SAVI Scout System cleared by the FDA?
Cianna Medical SAVI Scout Reflector and SAVI Scout System (K171767) received a 510(k) decision of Substantially Equivalent on October 31, 2017, 139 days after the submission was received.
What is the product code of K171767?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.