# K122263: 14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel Use

- Pathway: 510(k) (Traditional)
- Applicant: Symmetry Medical
- Decided: Sep 28, 2012 after 63 days
- Product code: ODY (Tunneled Catheter Remover)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063048 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063048: Trans-Catheter Extractor, Tran Pa-C, Inc. (2007) Summary page 1.

## Indications for use
The Symmetry Surgical Single Use Cuffed Catheter Removal Device is a catheter accessory device intended for the minimally invasive removal of tunneled long term catheters. The Cuffed Catheter Removal Device is indicated for use with tunneled, double lumen Permcath catheters with sizes ranging from 6.0 French to 16.0 French

Source page: https://510kreport.com/device/K122263
Methodology: https://510kreport.com/methodology