FDA/CE Mark Statements

SurgiQuest AirSeal^® Technology
The SurgiQuest AirSeal^® Optical Trocar and Cannula System has received FDA 510(k) approval and has been cleared to market in the United States. Additionally, the device has received PQA Notified Body approval for CE Mark on the basis of examination under the requirements of Council Directive 93/42/EEC.

SurgiQuest AchorPort^® Technology
The SurgiQuest AnchorPort^® has received FDA 510(k) approval and has been cleared to market in the United States. Additionally, the device has received PQA Notified Body approval for CE Mark on the basis of examination under the requirements of Council Directive 93/42/EEC.