# K132169: Surgiquest Airseal Ifs

- Pathway: 510(k) (Special)
- Applicant: Surgiquest, Inc.
- Decided: Aug 22, 2013 after 38 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000, Surgiquest, Inc. (2011) Summary page 1.
- K121336: Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator Dpis 2000, Surgiquest, Inc. (2012) Summary page 1.

## 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 peritoneall 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/K132169
Methodology: https://510kreport.com/methodology