# K861323: Replacement Gastrostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Microvasive
- Decided: Dec 16, 1986 after 252 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 14, 2003 · Not classified · Z-0187-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0190-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0192-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0185-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0188-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0189-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0191-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0194-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0197-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0198-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0199-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0202-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0203-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0205-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0186-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0193-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0195-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0196-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0200-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0201-04: An increase in reported balloon failures, which may result in tube displacement.
- Nov 14, 2003 · Not classified · Z-0204-04: An increase in reported balloon failures, which may result in tube displacement.

Source page: https://510kreport.com/device/K861323
Methodology: https://510kreport.com/methodology