Tunneled Catheter Remover
The Tunneled Catheter Remover (product code ODY) is a general hospital device used to assist in the minimally invasive removal of tunneled long-term catheter cuffs by separating tissue ingrowth from the surrounding tissue, enabling safe removal of the catheter from the body. Tunneled catheters used for long-term vascular access develop fibrous tissue ingrowth around their cuffs, making removal challenging without dedicated instrumentation. This device is FDA Class 2 under regulation 880.5970 in the General Hospital specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
Research product code ODY in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- ODY
- Device Class
- FDA class 2
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.