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Deroyal Disposable Insufflation Tubing Filter

by Deroyal Industries, Inc.

510(k) K945789

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) K945789↗

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 NumberK945789 Date7 Feb 1995ClearedStatusActive
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  • Withdrawn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
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 Deroyal Disposable Insufflation Tubing Filter is a single-use device classified as a Laparoscopic Insufflator, designed to filter and regulate insufflation gas during laparoscopic procedures. It ensures clean airflow by removing particulate matter and contaminants from the gas stream, thereby maintaining surgical site sterility and reducing the risk of infection.

This filter is intended for use in obstetrics and gynecology settings, supplied as a sterile, disposable component. It is compatible with standard laparoscopic insufflation systems and is intended for single-use only. The device adheres to FDA 510(k) clearance and MDD regulations, with a classification under Device Class II (HIF product code). Proper storage requires protection from moisture and physical damage, and it must be discarded after use to prevent cross-contamination.

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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 Deroyal Disposable Insufflation Tubing Filter in laparoscopic procedures?

    The Deroyal Disposable Insufflation Tubing Filter is designed to filter and regulate insufflation gas during laparoscopic surgeries, specifically in obstetrics and gynecology settings. It removes particulate matter and contaminants from the gas stream to maintain surgical site sterility and reduce infection risks.

  • Is this device intended for single-use or can it be reused after cleaning?

    This device is explicitly intended for single-use only to prevent cross-contamination. The manufacturer advises discarding it after each procedure, as reuse is not supported or recommended.

  • How should the Deroyal Disposable Insufflation Tubing Filter be stored to ensure proper functionality?

    The device must be stored in a way that protects it from moisture and physical damage. Proper storage conditions are critical to maintaining its sterility and performance before use.

  • What regulatory pathways has this device undergone, and what does that mean for its use?

    The Deroyal Disposable Insufflation Tubing Filter has received FDA 510(k) clearance and complies with the Medical Device Directive (MDD). This classification under Device Class II (HIF product code) indicates it has been evaluated for safety and effectiveness, ensuring it meets regulatory standards for use in laparoscopic insufflation procedures.

  • Are there different sizes or models available for this tubing filter?

    The provided data does not specify multiple sizes or models for the Deroyal Disposable Insufflation Tubing Filter. It is described as a single standardized device for filtering insufflation gas in laparoscopic procedures, without variations mentioned in the documentation.