# K041453: Smith & Nephew Tumescent Catheter Inversion System, Model 7210023

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 22, 2004 after 51 days
- Product code: DWQ (Stripper, Vein, External)
- Device class: 2
- Regulation: 21 CFR 870.4885
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Codman® Disposable Vein Stripper (pre-amendment device): named in the summary without a submission number

## Recalls of this device
- Feb 24, 2015 · Class III · Z-1294-2015: Mislabeled with an incorrect expiration date

## Indications for use
The Smith & Nephew Tumescent Catheter Inversion System is intended to provide a system for removal of incompetent greater saphenous veins.

Source page: https://510kreport.com/device/K041453
Methodology: https://510kreport.com/methodology