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AirSeal iFS System - AirSeal iFS System

by Conmed Corporation

510(k) K230239

Active European Union and United States

CE MDD 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) K230239↗

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 NumberK230239 Date20 Sep 2023ClearedStatusActive
European UnionCE/MDD 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  • Withdrawn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/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
HIF
Models / Variants
AirSeal iFS System
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 AirSeal iFS System and AirSeal dV Solution are Laparoscopic Insufflators, designed to maintain pneumoperitoneum during minimally invasive surgical procedures. These devices regulate and monitor intra-abdominal pressure, ensuring stable conditions for laparoscopic interventions in obstetrics and gynecology.

Used in operating rooms, these systems are intended for single-use applications and are classified as Class II medical devices under FDA regulations. They are supplied sterile and require no additional sterilization. Compatible with MRI environments, the devices are authorized under FDA 510K clearance and MDD, adhering to regulatory standards for laparoscopic insufflation. Multiple model references are available, as listed in the device database.

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