Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SurgiQuest AIRSEAL iFS System

K-Number: K172516 · 2018-03-16

ApplicantConmed Corporation
Decision Date2018-03-16
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SurgiQuest AIRSEAL iFS System is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2018-03-16 under approval number K172516. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgiQuest AIRSEAL iFS System?

SurgiQuest AIRSEAL iFS System is a medical device that received FDA 510(k) clearance on 2018-03-16. It is manufactured by Conmed Corporation. The 510(k) number is K172516.

When was SurgiQuest AIRSEAL iFS System approved by the FDA?

SurgiQuest AIRSEAL iFS System received FDA 510(k) clearance on 2018-03-16, under approval number K172516.

What company makes SurgiQuest AIRSEAL iFS System?

SurgiQuest AIRSEAL iFS System is manufactured by Conmed Corporation.

What is the FDA product code for SurgiQuest AIRSEAL iFS System?

The FDA product code for SurgiQuest AIRSEAL iFS System is HIF.

Related Clinical Trials

NCT03418402 Post Operative Pain After Laparoscopic Hysterectomy Using Airseal® Versus Standard Insufflation System COMPLETED

Other Devices by Conmed Corporation

K151229ABC D-FLEX PROBE K161017True HD 3MOS Camera System K152969ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY K172940ANCHOR Tissue Retrieval System K172671HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal K171725CuffLink Implant System

View all 47 devices →

Related Devices (Code: HIF)

K162648U-Blade Veress NeedleTianjin Uwell Medical Device Manufacturing Co., Ltd. K153367S698 Symbioz flowSopro - Acteon Group K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC K162582HumiGard Surgical Humidification System, HumiGard Humdified Insufflation KitFisher & Paykel Healthcare K171139LaparoLight Veress NeedleBuffalo Filter, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑