# K910332: Flexiflo Sacks-Vine Gastrostomy Kits

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 19, 1991 after 53 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 4 (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 12, 2004 · Not classified · Z-0329-05: 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-0327-05: 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-0330-05: 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-0331-05: 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/K910332
Methodology: https://510kreport.com/methodology