# K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000

- Pathway: 510(k) (Traditional)
- Applicant: Surgiquest, Inc.
- Decided: May 25, 2011 after 159 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: 5 generations back to K964171 (1997). 23 ancestors in all.
35 later devices descend from it; 5 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071571: Surgiquest Airseal Optical Trocar & Cannula System, Surgiquest, Inc. (2007) Summary page 1.
- K083211: Airseal Optical Trocar & Cannula System, Surgiquest, Inc. (2008) Summary page 1.
- K092504: Surgiquest Airseal Optical Trocar and Cannula System, Surgiquest, Inc. (2009) Summary page 1.
- K063367: 45L Core Insufflator, Model F114, W.O.M. World of Medicine AG (2007) Summary page 1.

## Most influential descendants
- K143404: SurgiQuest AirSeal iFS System (2015), 27 descendants of its own
- K170784: Pneumoclear (2017), 17 descendants of its own
- K201361: Pneumoclear (2020), 14 descendants of its own
- K232610: da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation (2024), 11 descendants of its own
- K172516: SurgiQuest AIRSEAL iFS System (2018), 8 descendants of its own

## Indications for use
The SurgiQuest AirSeal ® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.

Source page: https://510kreport.com/device/K103692
Methodology: https://510kreport.com/methodology
