# K925102: Flexiflo Laparoscopic Jejunostomy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 9, 1994 after 609 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K160567: Barone Jejunostomy Catheter Set (2017), 0 descendants of its own

## Recalls of this device
- Jun 18, 2005 · Not classified · Z-0960-05: The kits contain a 12 Fr. Introducer Tear-Away BNS component . The manufacturer of the component B. Braun Medical Inc., Allentown, PA notified Abbott Laboratories by letter dated 5/27/05, that the tea
- Nov 12, 2004 · Not classified · Z-0338-05: Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Nov 12, 2004 · Not classified · Z-0328-05: Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.

Source page: https://510kreport.com/device/K925102
Methodology: https://510kreport.com/methodology