# K023261: Adapt Balloon Open Access Port, Model 41244

- Pathway: 510(k) (Traditional)
- Applicant: Taut, Inc.
- Decided: Dec 13, 2002 after 74 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112456: Adapt (TM) Universal Balloon Open Access Port (2011), 0 descendants of its own

## Indications for use
The ADAPtTMBalloon Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

Source page: https://510kreport.com/device/K023261
Methodology: https://510kreport.com/methodology