# K112456: Adapt (TM) Universal Balloon Open Access Port

- Pathway: 510(k) (Special)
- Applicant: Teleflexmedical, Inc.
- Decided: Oct 4, 2011 after 40 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010007 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023261: Adapt Balloon Open Access Port, Model 41244, Taut, Inc. (2002) Summary page 2.
- K082156: Adapt Universal Laparoscopic Port, Model 405940, 405912, 40591213, Teleflex Medical (2008) Summary page 2.

## Recalls of this device
- Mar 11, 2014 · Class II · Z-1290-2014: Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
- Mar 11, 2014 · Class II · Z-1289-2014: Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
- Mar 11, 2014 · Class II · Z-1328-2014: Complaints of leakage of insufflation gas through the device.
- Mar 11, 2014 · Class II · Z-1288-2014: Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
- Mar 11, 2014 · Class II · Z-1287-2014: Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
- Mar 11, 2014 · Class II · Z-1286-2014: 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 ADAPtTM Universal Balloon 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/K112456
Methodology: https://510kreport.com/methodology