# K972112: Intraducer Port SC Catalog#31275,31035,30915, and 31450

- Pathway: 510(k) (Traditional)
- Applicant: Taut, Inc.
- Decided: Dec 1, 1997 after 179 days
- Product code: GBW (Catheter, Peritoneal)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: none
- 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.

## Indications for use
THE DEVICE IS INTENDED FOR USE AS AN ABDOMINAL ACCESS PORT DURING LAPAROSCOPIC PROCEDURE AND THE VALVE FOR ATTACHING INSUFFLATION TUBING TO MAINTAIN PNEUMOPERITONEAL PRESSURE.

Source page: https://510kreport.com/device/K972112
Methodology: https://510kreport.com/methodology