# K992907: Intraducer

- Pathway: 510(k) (Traditional)
- Applicant: Taut, Inc.
- Decided: Oct 5, 1999 after 36 days
- Product code: GBW (Catheter, Peritoneal)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: 1 (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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 14, 2015 · Class II · Z-0277-2016: The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device

## Indications for use
Intended Use: To provide an access port into the peritoneal cavity.

Source page: https://510kreport.com/device/K992907
Methodology: https://510kreport.com/methodology