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Y-Type TUR/Bladder Irrigation Set

by Medline Industries, Inc.

510(k) K970946

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970946 Date10 Jun 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Medline Y-Type Tur/Bladder Irrigation Set
510(k) Number
FDA Product Code
LJH
Device Class
Class II
Regulation
21 CFR Part 876.5130
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.

This device is a System, Irrigation, Urological designed for continuous irrigation of the bladder during transurethral resection (TUR) procedures. It facilitates the infusion of sterile solutions to maintain visibility and clear debris during surgical interventions, such as prostate or bladder surgery.

The Y-Type TUR/Bladder Irrigation Set is a sterile, single-use device intended for use in urological procedures. It includes an 82-inch (2.1 m) length and a regulating clamp, supplied as a disposable system. The device is classified under FDA 510(k) clearance (K970946) and adheres to regulation number 876.5130, ensuring compliance with urological irrigation standards.

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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 types of surgical procedures is this irrigation set designed to support during bladder irrigation?

    This Y-Type TUR/Bladder Irrigation Set is specifically designed for continuous irrigation of the bladder during transurethral resection (TUR) procedures, such as prostate or bladder surgery. It helps maintain visibility and clear debris by infusing sterile solutions throughout the surgery.

  • Is this irrigation set reusable or intended for single-use only?

    The MEDLINE Y-Type TUR/Bladder Irrigation Set is explicitly labeled as a sterile, single-use device, meaning it is intended for one-time use only and should not be reused or reprocessed.

  • What is the length of the tubing included with this irrigation set, and how does it affect usability?

    The set includes an 82-inch (2.1-meter) length of tubing, which provides sufficient reach for most urological procedures while maintaining flexibility and ease of maneuverability during surgery.

  • Does this device come with any additional components, and if so, what are they?

    Yes, the Y-Type TUR/Bladder Irrigation Set is supplied as a disposable system that includes a regulating clamp, allowing the user to control the flow rate of the irrigation solution during the procedure.

  • How should this irrigation set be stored, and are there any special handling requirements?

    Since it is a sterile, single-use device, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. The packaging should remain intact until immediate use to maintain sterility.