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SurgiQuest AIRSEAL iFS System

by Conmed Corporation

510(k) K172516

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172516↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK172516 Date16 Mar 2018ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
HIF
Device Class
Class II
Regulation
21 CFR Part 884.1730
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SurgiQuest AirSeal iFS System is a laparoscopic insufflator designed to maintain stable pneumoperitoneum during minimally invasive surgical procedures. It integrates insufflation with continuous smoke evacuation, eliminating the need for separate smoke extraction systems while ensuring clear visualization and pressure control.

This system is intended for single-use in operating room settings and is classified as a Class II medical device under FDA regulations. It is supplied as a sterile, disposable device and is compatible with MRI environments. The system is authorised under FDA 510(k) clearance (K172516) and the EU Medical Device Regulation (MDR), with product code HIF. Storage and handling must adhere to manufacturer guidelines to preserve sterility and functionality.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the SurgiQuest AIRSEAL iFS System in surgical settings?

    The SurgiQuest AIRSEAL iFS System is designed to maintain stable pneumoperitoneum during minimally invasive surgical procedures. Unlike traditional insufflators, it integrates insufflation with continuous smoke evacuation, eliminating the need for separate smoke extraction systems. This dual functionality ensures clear visualization and precise pressure control throughout the procedure.

  • Is the SurgiQuest AIRSEAL iFS System intended for reuse, or is it meant to be used only once?

    The SurgiQuest AIRSEAL iFS System is explicitly designed for single-use in operating room settings. This ensures sterility and safety for each patient, as reuse could compromise its performance and integrity.

  • How should the SurgiQuest AIRSEAL iFS System be stored to maintain its sterility and functionality?

    The system must be stored and handled according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is a sterile, disposable device, it should remain in its original packaging until ready for use, and any exposure to contamination or improper storage conditions could void its intended performance.

  • Can the SurgiQuest AIRSEAL iFS System be used in MRI environments, and if so, why?

    Yes, the SurgiQuest AIRSEAL iFS System is explicitly compatible with MRI environments. This means it can be safely used in operating rooms equipped with MRI machines without interfering with imaging or posing risks to patients or staff.

  • What regulatory pathways has the SurgiQuest AIRSEAL iFS System undergone, and what does that mean for its use?

    The system has received FDA 510(k) clearance (K172516) and authorization under the EU Medical Device Regulation (MDR). This indicates that it has met regulatory standards for safety and effectiveness in the U.S. and EU markets, allowing its use in approved clinical settings under the specified indications. The clearance type is 'Traditional,' and it falls under the Obstetrics/Gynecology advisory committee category.