# K172516: SurgiQuest AIRSEAL iFS System

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Mar 16, 2018 after 207 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). 30 ancestors in all.
8 later devices descend from it; 2 cite it directly.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143404: SurgiQuest AirSeal iFS System, Surgiquest, Inc. (2015) Summary page 4.

## Most influential descendants
- K193520: EVA 15 Insufflator (2020), 5 descendants of its own
- K202799: EVA15 (2020), 4 descendants of its own
- K222901: EVA15 insufflator (2023), 3 descendants of its own
- K230474: EVA5 Insufflator (2023), 1 descendant of its own
- K190303: AirSeal (2019), 1 descendant of its own

## Indications for use
The SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. It is indicated to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

Source page: https://510kreport.com/device/K172516
Methodology: https://510kreport.com/methodology