# K093312: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access Dilation System

- Pathway: 510(k) (Special)
- Applicant: Kimberly-Clark Corp.
- Decided: Dec 8, 2009 after 47 days
- Product code: KGC (Tube, Gastro-Enterostomy)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K852363 (1985). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080253: Kimberly-Clark Introducer Kits, Kimberly-Clark Corp. (2008) Summary page 1.

## Most influential descendants
- K183057: PUMA-G System (2019), 2 descendants of its own
- K223916: PUMA-G System (2023), 1 descendant of its own
- K170020: Peel-Away Introducer Set (2017), 1 descendant of its own
- K242211: PUMA-G Pediatric System (2025), 0 descendants of its own
- K173685: Peel-Away Introducer Set (2017), 0 descendants of its own

## Indications for use
The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-PeXyTm T-Fasteners is intended to affix the stomach to the anterior abdominal wail facilitating primary placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these T-Fasteners be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes. The Kimberly-Clark Enteral Acccess Dilation System is intended to facilitate stoma tract dilation prior to placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these dilator be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes

Source page: https://510kreport.com/device/K093312
Methodology: https://510kreport.com/methodology