# Tunneled Catheter Remover
> **Product code: ODY** · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5970
## Classification
- **FDA Product Code:** ODY
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 880.5970
- **Review panel:** HO
- **Medical specialty:** General Hospital
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 9
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=ODY)
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