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Laparoscopic Suction Irrigation Tubing Set

by United States Endoscopy Group, Inc.

510(k) K911484

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 NumberK911484 Date23 Apr 1991ClearedStatusActive

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  • Withdrawn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
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 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 Suction Irrigation Tubing Set, classified under product code GCJ. It is designed for use in laparoscopic procedures to facilitate suction and irrigation within the abdominal cavity, aiding in fluid management, visualization, and maintenance of a clear operative field during minimally invasive surgery.

The set is intended for single-use and is supplied sterile. It includes tubing components compatible with laparoscopic instruments and irrigation/suction systems. The device holds FDA 510(k) clearance (K911484) under the Traditional pathway, with a decision date of April 23, 1991. No MRI safety information is specified, and storage conditions are not detailed in the regulatory submission.

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