# K103109: Ponsky* Non-Balloon Replacement Gastrostomy Tube

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 22, 2010 after 62 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: 1 generation back to K915837 (1993). 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)
- K915837: Non-Balloon Replacement Gastrostomy System, C.R. Bard, Inc. (1993) Summary page 1.

## Most influential descendants
- K182248: Aspire Venting Tube (2018), 0 descendants of its own

## Indications for use
For percutaneous placement of a long-term replacement gastrostomy feeding and/or decompression device into an established stoma.

Source page: https://510kreport.com/device/K103109
Methodology: https://510kreport.com/methodology