Biopsy needles
COX for MEDONE
A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.
COX for MEDONE models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| CO12100-00 | — | MR Unsafe | Available |
| CO12160-00 | — | MR Unsafe | Available |
| CO14100-00 | — | MR Unsafe | Available |
| CO14160-00 | — | MR Unsafe | Available |
| CO16100-00 | — | MR Unsafe | Available |
| CO16160-00 | — | MR Unsafe | Available |
| CO16200-00 | — | MR Unsafe | Available |
| CO18100-00 | — | MR Unsafe | Available |
| CO18160-00 | — | MR Unsafe | Available |
| CO18160-10 | — | MR Unsafe | Available |
| CO18200-00 | — | MR Unsafe | Available |
| CO20100-00 | — | MR Unsafe | Available |
| CO20100-10 | — | MR Unsafe | Available |
| CO20160-00 | — | MR Unsafe | Available |
| CO20200-00 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K142125 December 2015
Procedures that use biopsy needles
Frequently asked questions
What is COX for MEDONE used for?
A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.
Who makes COX for MEDONE?
COX for MEDONE is made by Medax Srl Unipersonale. It is listed under biopsy needles and systems in our device library.
What sizes does COX for MEDONE come in?
The FDA device database does not list sizes for COX for MEDONE. Check the instructions for use or ask a Medax Srl Unipersonale representative.
Is COX for MEDONE MRI safe?
The FDA device database lists COX for MEDONE as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is COX for MEDONE FDA cleared?
COX for MEDONE is covered by FDA submission K142125.
How do I contact a Medax Srl Unipersonale sales representative?
Medax Srl Unipersonale has not listed representatives on LA Vascular yet. Visit the Medax Srl Unipersonale company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.