# K140263: Insuflow Synergy Port, Insuflow Synergy XL Port

- Pathway: 510(k) (Special)
- Applicant: Lexion Medical, LLC
- Decided: Mar 5, 2014 after 30 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: 8 generations back to K964171 (1997). 36 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 39 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.
- K132204: Insuflow Synergy XL Port, Lexion Medical, LLC (2013) Summary page 1.
- K032676: Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar, Ethicon Endo-Surgery, Inc. (2003) Summary page 1.
- K121336: Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator Dpis 2000, Surgiquest, Inc. (2012) Summary page 1.

## Most influential descendants
- 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™ Port (5 mm) and Insuflow® Synergy™ XL Port (8 mm, 10 mm and 12 mm) 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/K140263
Methodology: https://510kreport.com/methodology