The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Surgiquest Airseal Ifs System.
Device ID | K172516 |
510k Number | K172516 |
Device Name: | SurgiQuest AIRSEAL IFS System |
Classification | Insufflator, Laparoscopic |
Applicant | ConMed Corporation 488 Wheelers Farms Road Milford, CT 06461 |
Contact | Lisa Anderson |
Correspondent | Michael Daniel Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, NV 89460 |
Product Code | HIF |
CFR Regulation Number | 884.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-21 |
Decision Date | 2018-03-16 |
Summary: | summary |