# K132204: Insuflow Synergy XL Port

- Pathway: 510(k) (Special)
- Applicant: Lexion Medical, LLC
- Decided: Aug 22, 2013 after 37 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K964171 (1997). 34 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120640: Insuflow Synergy Port, Lexion Medical, LLC (2012) Summary page 1.
- K032676: Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar, Ethicon Endo-Surgery, Inc. (2003) Summary page 1.

## Most influential descendants
- K140263: Insuflow Synergy Port, Insuflow Synergy XL Port (2014), 2 descendants of its own
- K170799: AP 50/30 Insufflator with Insuflow Port (2017), 1 descendant of its own
- K191780: AP50/30 Insufflator with Insuflow Port (2019), 0 descendants of its own

## Indications for use
Insuflow Synergy XL Port (10mm and 12mm) and Insuflow Synergy XLR Port (10mm and 12mm with endoscopic cannula seal) have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO₂ gas stream for insufflation of the surgical cavity.

Source page: https://510kreport.com/device/K132204
Methodology: https://510kreport.com/methodology