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Irrigation System

by United States Endoscopy Group, Inc.

510(k) K103239

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK103239 Date30 Dec 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1099-2013 FDA Class II initiated 7 Mar 2013

    The firm was notified by their customers that there was a water leakage from the white tubing connector.

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  • Withdrawn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

Overview

AI-generated summary, 27 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 Irrigation System is an endoscopic irrigation/suction system designed for medical procedures in gastroenterology and urology. It provides irrigation and suction capabilities during endoscopic procedures.

The device is supplied as a reusable system and is not MRI compatible. It is authorized under FDA 510(k) clearance with product code OCX and regulation number 876.1500. The system is manufactured by United States Endoscopy Group, Inc. and is available in various models as indicated by the multiple registration numbers.

Other devices from United States Endoscopy Group, Inc.

See all devices from United States Endoscopy Group, Inc. →

Questions

AI-generated answers, 27 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 Irrigation System used for?

    The Irrigation System is designed for medical procedures in gastroenterology and urology, providing irrigation and suction capabilities during endoscopic procedures. It is a reusable system that helps maintain clear visualization during these specialized medical interventions.

  • Is the Irrigation System MRI compatible?

    No, the Irrigation System is not MRI compatible. It is designed specifically for standard endoscopic procedures and should not be used in MRI environments due to potential safety risks and device limitations.

  • How is the Irrigation System supplied and what models are available?

    The Irrigation System is supplied as a reusable system and is available in various models as indicated by the multiple registration numbers. Each model may have specific features or configurations tailored to different procedural needs in gastroenterology and urology.

  • What is the regulatory status of the Irrigation System?

    The Irrigation System is authorized under FDA 510(k) clearance with product code OCX and regulation number 876.1500. It has been determined to be substantially equivalent to predicate devices for use in gastroenterology and urology procedures.