# K083211: Airseal Optical Trocar & Cannula System

- Pathway: 510(k) (Traditional)
- Applicant: Surgiquest, Inc.
- Decided: Dec 15, 2008 after 45 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: 2 generations back to K903419 (1990). 5 ancestors in all.
51 later devices descend from it; 2 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903419: Modified Surgiport Disposable Trocar and Sleeve, United States Surgical, A Division of Tyco Healthc (1990) Summary page 1.
- K032676: Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar, Ethicon Endo-Surgery, Inc. (2003) Summary page 1.
- K063859: Surgiquest Elastomeric Optical Trocar & Cannula, Surgiquest, Inc. (2007) Summary page 1.
- K052797: Lapevac, Filtration Device for the Periotoneum, Medtek Devices, Inc. (2006) Summary page 1.
- K911154: Sun Medical Smoke/Fluid Evac Syst, Model Sfe-200, Sun Medical, Inc. (1991) Summary page 1.

## Most influential descendants
- K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000 (2011), 35 descendants of its own
- 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
- K112642: Aquilex Fluid Control System H112 (2012), 14 descendants of its own

## Indications for use
The SurgiQuest AirSealTM Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions.

Source page: https://510kreport.com/device/K083211
Methodology: https://510kreport.com/methodology