# K021731: Adapt Open Access Port, Model 41233

- Pathway: 510(k) (Traditional)
- Applicant: Taut, Inc.
- Decided: Aug 8, 2002 after 76 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (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
- Mar 11, 2014 · Class II · Z-1327-2014: Complaints of leakage of insufflation gas through the device.
- Mar 11, 2014 · Class II · Z-1285-2014: Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

## Indications for use
The ADAPtTMOpen 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/K021731
Methodology: https://510kreport.com/methodology