# K082156: Adapt Universal Laparoscopic Port, Model 405940, 405912, 40591213

- Pathway: 510(k) (Special)
- Applicant: Teleflex Medical
- Decided: Sep 10, 2008 after 42 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010007 (2001). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010007: Adapt Laparoscopic Port & Adapt Reducer Cap, Taut, Inc. (2001) Summary page 2.

## Most influential descendants
- K121796: Weck Reusable Obturator (2012), 0 descendants of its own
- K121380: Weck Vista Optical Bladeless Laparoscopic Access Port (2012), 0 descendants of its own
- K112456: Adapt (TM) Universal Balloon Open Access Port (2011), 0 descendants of its own

## Recalls of this device
- Mar 11, 2014 · Class II · Z-1280-2014: 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-1281-2014: 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-1276-2014: 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-1323-2014: Complaints of leakage of insufflation gas through the device.
- May 12, 2010 · Not classified · Z-1890-2010: Balloon does not hold air or water once inflated.

## Indications for use
The ADAPt™ Universal Laparoscopic 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/K082156
Methodology: https://510kreport.com/methodology