Biopsy needles
COX for MEDCUT
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 MEDCUT 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 |
|---|---|---|---|
| CM14100-00 | — | MR Unsafe | Available |
| CM16100-00 | — | MR Unsafe | Available |
| CM16160-00 | — | MR Unsafe | Available |
| CM16200-00 | — | MR Unsafe | Available |
| CM18100-00 | — | MR Unsafe | Available |
| CM18160-00 | — | MR Unsafe | Available |
| CM18200-00 | — | MR Unsafe | Available |
| CM20160-00 | — | MR Unsafe | Available |
| CM20200-00 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K142125 December 2015
Procedures that use biopsy needles
Frequently asked questions
What is COX for MEDCUT 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 MEDCUT?
COX for MEDCUT is made by Medax Srl Unipersonale. It is listed under biopsy needles and systems in our device library.
What sizes does COX for MEDCUT come in?
The FDA device database does not list sizes for COX for MEDCUT. Check the instructions for use or ask a Medax Srl Unipersonale representative.
Is COX for MEDCUT MRI safe?
The FDA device database lists COX for MEDCUT as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is COX for MEDCUT FDA cleared?
COX for MEDCUT 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.