# K211104: AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Aug 19, 2021 after 128 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: 10 generations back to K964171 (1997). 32 ancestors in all.
No later device cites it as a predicate yet.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190303: AirSeal, Conmed Corporation (2019) Summary page 4.

## Indications for use
The AirSeal® dV Solution, AirSeal Cannula Cap and AirSeal Bifurcated Filtered Tube Set, is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci Xi and da Vinci X Cannula to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric (> 20kg) procedures where insufflation is desired to facilitate the use of various laparoscopic and thoracoscopic 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. The obturator of the Cannula Cap is indicated for use with or without visualization. The AirSeal Cannula Cap and Bifurcated Filtered Tube Set must be used with the Intuitive da Vinci Xi and da Vinci X 8 mm Instrument Cannula, an Intuitive Cannula Seal and the AirSeal iFS in AirSeal mode. When used in AirSeal mode, the Cannula Cap and Bifurcated Tube Set are designed to provide CO2 gas delivery with stable pneumoperitoneum and continuous smoke evacuation during robotic assisted laparoscopic and thoracoscopic procedures using the da Vinci Xi or da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Cap and Cannula Seal to the AirSeal iFS.

Source page: https://510kreport.com/device/K211104
Methodology: https://510kreport.com/methodology