# K910492: Bard Replacement Gastrostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 24, 1991 after 169 days
- Product code: KGC (Tube, Gastro-Enterostomy)
- 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
- Apr 6, 2006 · Not classified · Z-0838-06: Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated 
- Apr 6, 2006 · Not classified · Z-0836-06: Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated 
- Apr 6, 2006 · Not classified · Z-0837-06: Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated 
- Apr 6, 2006 · Not classified · Z-0839-06: Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated 

Source page: https://510kreport.com/device/K910492
Methodology: https://510kreport.com/methodology