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Deroyal Surgical Disposable Insufflation Tubing

by Deroyal Industries, Inc.

510(k) K934131

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK934131 Date7 Mar 1994ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 19 Sep 2026

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

This device is a Laparoscopic Insufflator Tubing Set, designed for use with insufflation systems to introduce gas into the abdominal cavity during minimally invasive surgical procedures. It facilitates controlled insufflation by delivering carbon dioxide (CO₂) while maintaining sterility and preventing contamination through integrated filtration.

The tubing is supplied as a single-use, disposable item, featuring a rotating luer-lock connector to prevent accidental disconnection and a color-coded design for easy identification. Available in sizes with bidirectional hydrophobic filters (0.1 or 0.3 microns), it is intended for use in obstetrics and gynecology procedures. The device holds FDA 510(k) clearance under the classification of Class II medical devices, adhering to regulatory standards for surgical insufflation applications.

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