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Hydro-Flex LI Laparoscopic Irrigation System

by Davol Inc., Sub. C. R. Bard, Inc. 510(k)

Active United States

510(k) K961224

Overview

The Hydro-Flex LI Laparoscopic Irrigation System is a device designed to provide controlled irrigation during laparoscopic procedures. It helps flush blood and tissue debris from the operative site to aid in visualization during laparoscopy.

The system is supplied as a reusable irrigation system with variable pressure and front panel control buttons. It is distributed by Davol Inc., Sub. C.R. Bard, Inc., and has received FDA 510(k) clearance under K961224, with a decision date of May 16, 1996.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961224 Date16 May 1996ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the Hydro-Flex LI Laparoscopic Irrigation System used for?

    The Hydro-Flex LI Laparoscopic Irrigation System is designed to provide controlled irrigation during laparoscopic procedures to flush blood and tissue debris from the operative site, aiding in visualization during laparoscopy.

  • Is the Hydro-Flex LI Laparoscopic Irrigation System reusable or single-use?

    The Hydro-Flex LI Laparoscopic Irrigation System is supplied as a reusable irrigation system, meaning it can be cleaned and used for multiple procedures following appropriate reprocessing protocols.

  • How is the Hydro-Flex LI Laparoscopic Irrigation System controlled during use?

    The system features variable pressure settings and front panel control buttons, allowing the user to adjust irrigation flow and pressure as needed during laparoscopic procedures.

  • What regulatory clearance does the Hydro-Flex LI Laparoscopic Irrigation System have?

    The Hydro-Flex LI Laparoscopic Irrigation System has received FDA 510(k) clearance under K961224, with a decision date of May 16, 1996, and is classified as substantially equivalent to a predicate device.