AirSeal® DV Solution- AirSeal® Cannula Cap And AirSeal® Bifurcated Filtered Tube Set

Insufflator, Laparoscopic

ConMed Corporation

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Airseal® Dv Solution- Airseal® Cannula Cap And Airseal® Bifurcated Filtered Tube Set.

Pre-market Notification Details

• Device ID: K211104
• 510k Number: K211104
• Device Name: AirSeal® DV Solution- AirSeal® Cannula Cap And AirSeal® Bifurcated Filtered Tube Set
• Classification: Insufflator, Laparoscopic
• Applicant: ConMed Corporation 525 French Road Utica, NY 13502
• Contact: Ally Xu
• Correspondent: Ally Xu; ConMed Corporation 525 French Road Utica, NY 13502
• Product Code: HIF
• CFR Regulation Number: 884.1730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-13
• Decision Date: 2021-08-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20845854051402	K211104	000
20845854051396	K211104	000