# K080253: Kimberly-Clark Introducer Kits

- Pathway: 510(k) (Special)
- Applicant: Kimberly-Clark Corp.
- Decided: Feb 26, 2008 after 26 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: 1 generation back to K852363 (1985). 3 ancestors in all.
10 later devices descend from it; 4 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852363: Mic Gastrostomy Tube Percutaneous Insertion Kit, Medical Innovations Corp. (1985) Summary page 1.
- K921370: Mic Gastro-Enterostomy Tube Modification, Medical Innovations Corp. (1994) Summary page 1.
- K926581: Mic Transgastric Jejunal Tube, Medical Innovations Corp. (1994) Summary page 1.

## Most influential descendants
- K093312: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access Dilation System (2009), 5 descendants of its own
- K183057: PUMA-G System (2019), 2 descendants of its own
- K092049: Iyunni 3ID Tri-Funnel Gastrostomy Tube Kit (2009), 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

## Indications for use
The Kimberly-Clark* MIC* G Introducer Kits are intended to facilitate primary placement of Kimberly-Clark* and Kimberly-Clark* MIC* brand of Gastrostomy Feeding Tubes. The Kimberly-Clark* MIC-KEY* G Introducer Kits are intended to facilitate primary placement of Kimberly-Clark* and Kimberly-Clark* MIC-KEY* brand of Gastrostomy Feeding Tubes. The Kimberly-Clark* MIC* Jejunal and Kimberly-Clark* MIC* Transgastric-Jejunal Introducer Kit is intended to facilitate primary placement of Kimberly-Clark* MIC* Jejunal Feeding Tube and the Kimberly-Clark* MIC* Transgastric-Jejunal Feeding Tube. The Kimberly-Clark* MIC-KEY* Jejunal and Kimberly-Clark* MIC-KEY* Transgastric-Jejunal Introducer Kit is intended to facilitate primary placement of Kimberly-Clark* MIC-KEY* Low-Profile Jejunal Feeding Tube and the Kimberly-Clark* MIC-KEY* Low-Profile Transgastric-Jejunal Feeding Tube.

Source page: https://510kreport.com/device/K080253
Methodology: https://510kreport.com/methodology