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Defendo Y-Opsy Irrigator

by Byrne Medical Incorporated

510(k) K110088

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 NumberK110088 Date10 Jun 2011ClearedStatusActive

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  • Withdrawn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
ODC
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
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.

The Defendo Y-Opsy Irrigator is an Endoscope Channel Accessory, designed for irrigation within endoscopic procedures. It facilitates fluid delivery through the working channel of a gastroscope or cystoscope, aiding in visualization, cleaning, and irrigation during diagnostic or therapeutic interventions in gastroenterology and urology.

This single-use, sterile device is intended for use with Olympus and Fujifilm gastrointestinal endoscopes, supplied in packs of 50 units per box. It complies with FDA 510(k) clearance (K110088) under the classification 876.1500 and is intended for reusable endoscope channels. No MRI safety information is specified, and it is not intended for reusable use outside its designated single-use application.

Questions

AI-generated answers, 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.

  • What medical specialties is the Defendo Y-Opsy Irrigator primarily intended for use in, and how does it assist during procedures in those fields?

    The Defendo Y-Opsy Irrigator is designed for use in gastroenterology and urology, where it aids in irrigation through the working channel of an Olympus or Fujifilm gastroscope or cystoscope. It helps improve visualization, clean the channel, and facilitate irrigation during diagnostic or therapeutic interventions, such as biopsies, stone removal, or other endoscopic procedures.

  • Is the Defendo Y-Opsy Irrigator reusable, or is it meant for single-use only? If single-use, how many units are included in a box?

    The Defendo Y-Opsy Irrigator is strictly single-use only and not intended for reuse outside its designated application. Each box contains 50 units, providing a cost-effective solution for procedural workflows.

  • Which brands of endoscopes is this irrigator compatible with, and does it require any special preparation before use?

    The Defendo Y-Opsy Irrigator is compatible only with Olympus and Fujifilm gastrointestinal endoscopes and is designed for use with their reusable working channels. Since it is sterile upon packaging, no additional preparation is required before use—simply attach it to the endoscope’s channel for irrigation.

  • How is the Defendo Y-Opsy Irrigator packaged, and what should be considered for storage to maintain its sterility?

    The device is supplied in sterile packs of 50 units per box, ensuring readiness for immediate use. To preserve sterility, storage should occur in a clean, dry environment away from direct sunlight or extreme temperatures, following standard single-use medical device storage guidelines.