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Cianna Medical SAVI Scout Reflector and SAVI Scout System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181007

by Cianna Medical, Inc.

Identifiers

510(k) Number
K181007 FDA 510(k)
FDA Product Code
NEU FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4300 FDA 510(k)
Regulation Number
878.4300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cianna Medical SAVI Scout Reflector and SAVI Scout System is a Marker, Radiographic, Implantable device used in General and Plastic Surgery specialties. The SAVI Scout Reflector is intended to be placed percutaneously in soft tissue to mark a biopsy site or a soft tissue site intended for surgical removal, with marking duration exceeding 30 days.

The SAVI Scout Reflector is located using imaging guidance such as ultrasound, MRI, or radiography, or aided by non-imaging guidance from the SAVI Scout System, and is surgically removed with the target tissue. The device is authorized under FDA 510(k) clearance K181007, product code NEU, regulation number 878.4300, and decision date 2018-08-02.

Frequently asked questions

What is the SAVI Scout Reflector used for?

The SAVI Scout Reflector is an implantable marker intended to be placed percutaneously in soft tissue. It marks a biopsy site or a soft tissue site intended for surgical removal, with a marking duration exceeding 30 days.

How is the SAVI Scout Reflector located?

The device is located using imaging guidance such as ultrasound, MRI, or radiography. It can also be aided by non-imaging guidance from the SAVI Scout System.

How is the SAVI Scout Reflector removed?

The SAVI Scout Reflector is surgically removed with the target tissue, which is the tissue it was intended to mark.

What is the regulatory status of the SAVI Scout Reflector?

The device is authorized under FDA 510(k) clearance K181007.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cianna Medical SAVI Scout Reflector and SAVI Scout System (K181007 ..., Cianna Medical SAVI Scout Reflector And SAVI Scout… - FDA.report, Cianna Medical SAVI Scout Reflector And SAVI Scout System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cianna Medical, Inc.

Sources (1)

  • FDA 510(k) K181007 24 fields · synced Oct 6, 2026