# K060897: Embedding Tool, Model TE-1000

- Pathway: 510(k) (Traditional)
- Applicant: Medigroup, Inc.
- Decided: Jul 18, 2006 after 106 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
Longest line of descent: 1 generation back to K823331 (1983). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K823331: PC-204 Tunnelor, Medigroup (1983) Summary page 1.

## Most influential descendants
- K213602: Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit (2022), 0 descendants of its own

## Indications for use
This device can be used to embed most known brands and styles of PD catheters when the nephrologist determines this action is in the best interest of the patient, however, only immediately after successful catheter implantation. The Embedding Tm Tool is indicated for embedding the external portion of most PID catheters subcutaneously in anticipation of future retrieval of that part of the catheter, provided that: * The embedding procedure is done immediately following PD catheter implantation. * Catheter patency has been completely established. * The normally external part of the PD catheter can be embedded. * The patient is a candidate for delayed onset of PD treatment. * The patient is a candidate for PD.

Source page: https://510kreport.com/device/K060897
Methodology: https://510kreport.com/methodology