# K121336: Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator Dpis 2000

- Pathway: 510(k) (Special)
- Applicant: Surgiquest, Inc.
- Decided: Jul 3, 2012 after 61 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: 6 generations back to K964171 (1997). 24 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 29 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.

## 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
- K132169: Surgiquest Airseal Ifs (2013), 0 descendants of its own

## Indications for use
The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator OPIS 2000 (the "OPIS 2000 System") is intended for use in diagnostic and/or therapeutic endloscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endloscopic 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/K121336
Methodology: https://510kreport.com/methodology