AirSeal

Insufflator, Laparoscopic

ConMed Corporation

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Airseal.

Pre-market Notification Details

• Device ID: K190303
• 510k Number: K190303
• Device Name: AirSeal
• Classification: Insufflator, Laparoscopic
• Applicant: ConMed Corporation 525 French Road Utica, NY 13502
• Contact: Lisa Anderson
• Correspondent: Lisa Anderson; 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: 2019-02-12
• Decision Date: 2019-03-28