Helix Hydro-Jet

FDA 510(k) K022613 · Erbe USA, Inc.

Substantially Equivalent

510(k) numberK022613

Submission

Device name
Helix Hydro-Jet
Applicant
Erbe USA, Inc.
Marietta, GA, US
Received
August 6, 2002
Decision date
October 25, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FQH – Lavage, Jet
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5475
Specialty
General Hospital

Other 510(k)s with product code FQH

510(k)DeviceApplicantDecision
K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)FQH · Special Becton, Dickinson and Company (BD)02/25/2026SE
K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)FQH · Traditional Bd02/20/2026SE
K231023ERBEJET® 2 SystemFQH · Traditional Erbe Elektromedizin GmbH06/15/2023SE
K220759Armis VeriCyn Wound WashFQH · Traditional Armis Biopharma, Inc.05/25/2023SE
K220964VERSAJET Hydrosurgery System (III)FQH · Traditional Smith & Nephew Medical Limited05/16/2023SE
K221504BD Surgiphor™ Antimicrobial Irrigation SystemFQH · Traditional Bd10/14/2022SE
K222804Irrisept Antimicrobial Wound LavageFQH · Special Irrimax Corporation09/22/2022SE
K210987IRRIGO Wound Wash Jet SystemFQH · Traditional Inopro, Inc.05/31/2022SE
K213616BD Surgiphor Antimicrobial Irrigation SystemFQH · Traditional Becton, Dickinson and Company03/23/2022SE
K210536Irrisept Antimicrobial Wound LavageFQH · Traditional Irrimax Corporation05/28/2021SE

More from Irrimax Corporation

510(k)DeviceDecision
K221177Erbe's Tubing/Cap SetsOCX · Traditional 08/11/2022SE
K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorOCX · Special 06/27/2019SE
K190469ERBEFLO 2 Disposable Tubing SystemOCX · Traditional 05/23/2019SE
K182444ERBEFLO Olympus Scope Port ConnectorOCX · Traditional 11/06/2018SE
K162152Erbe’s CO2 Tubing/Cap SetsFEQ · Special 08/31/2016SE
K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeGEI · Traditional 10/27/2015SE
K151041ERBECRYO 2 Cryosurgical Unit with accessoriesGEH · Special 05/04/2015SE
K143186Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port…OCX · Special 12/18/2014SE
K132340Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…FEQ · Traditional 12/17/2013SE
K133180Erbe Esu Model Vio DV with AccessoriesGEI · Special 12/11/2013SE

Questions and answers

When was Helix Hydro-Jet cleared by the FDA?

Helix Hydro-Jet (K022613) received a 510(k) decision of Substantially Equivalent on October 25, 2002, 80 days after the submission was received.

What is the product code of K022613?

The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.