# K012502: Medigroup Catheter Extender/Repair Kit

- Pathway: 510(k) (Traditional)
- Applicant: Janin Group, Inc.
- Decided: Feb 4, 2002 after 185 days
- Product code: FJS (Catheter, Peritoneal, Long-Term Indwelling)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- 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) Extender/Repair Kit marketed by Kendall, Quinton: named in the summary without a submission number

## Indications for use
This device is intended for use with Flex-Neck™ catheters and Ash Advantage™ catheters in the event one of two situations described below should occur: 1. Extender Application In some patients, the external portion of the PD catheter may be too short for them to comfortably use. For example, obese patients may need an extender kit to be able to work with the external part of the catheter. Other patients may require the external end of the catheter to be more centrally located than it normally might be. 2. Repair Application If a peritoneal dialysis catheter develops a fracture in the external portion, the catheter must be trimmed to eliminate the fracture. Doing so, by definition, will shorten the catheter and may make it impractical or difficult or even unsuitable for use. Rather than replace the entire catheter, it is desirable to retain the catheter by extending the external part of the catheter with new tubing. In either situation, this device enables qualified medical staff to extend and/or repair the external part of an existing Flex-Neck catheter or Ash Advantage catheter by adding a 20 cm long tube to the existing and/or remaining catheter tubing.

Source page: https://510kreport.com/device/K012502
Methodology: https://510kreport.com/methodology