# K041034: Skin Level Gastrostomy Tube Kit (Ecsl)

- Pathway: 510(k) (Traditional)
- Applicant: Entracare, LLC
- Decided: Aug 31, 2004 after 132 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- 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 K922667 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993138: Ballard Mic-Key G Low Profile Gastrostomy Replacement Kit, Ballard Medical Products (1999) Summary page 3.

## Indications for use
The ECSL is a low profile balloon gastrostomy tube indicated for use as a replacement tube in an established stoma tract for pediatric, adult and elderly patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients with a functioning gut who require long term feeding support. This may include patients for whom malnutrition already exists or may result, secondary to neurological diseases resulting in an abnormality in swallowing; tumors of the head, neck or esophagus; or upper airway diseases or oropharyngeal trauma resulting in an abnormality in swallowing. Some patients who require chronic use of supplemental fluids are also candidates for gastrostomy tube use.

Source page: https://510kreport.com/device/K041034
Methodology: https://510kreport.com/methodology