Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5475](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5475) → FQH — Lavage, Jet # FQH · Lavage, Jet _General Hospital · 21 CFR 880.5475 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH ## Overview - **Product Code:** FQH - **Device Name:** Lavage, Jet - **Regulation:** [21 CFR 880.5475](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5475) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## Identification A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. ## Recent Cleared Devices (20 of 53) Showing 20 most recent of 53 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253996](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K253996.md) | BD Surgiphor™ Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | Feb 25, 2026 | SESE | | [K253445](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K253445.md) | BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) | Bd | Feb 20, 2026 | SESE | | [K231023](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K231023.md) | ERBEJET® 2 System | Erbe Elektromedizin GmbH | Jun 15, 2023 | SESE | | [K220759](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K220759.md) | Armis VeriCyn Wound Wash | Armis Biopharma, Inc. | May 25, 2023 | SESE | | [K220964](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K220964.md) | VERSAJET Hydrosurgery System (III) | Smith & Nephew Medical Limited | May 16, 2023 | SESE | | [K221504](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K221504.md) | BD Surgiphor™ Antimicrobial Irrigation System | Bd | Oct 14, 2022 | SESE | | [K222804](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K222804.md) | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | Sep 22, 2022 | SESE | | [K210987](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K210987.md) | IRRIGO Wound Wash Jet System | Inopro, Inc. | May 31, 2022 | SESE | | [K213616](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K213616.md) | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | Mar 23, 2022 | SESE | | [K210536](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K210536.md) | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | May 28, 2021 | SESE | | [K202222](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K202222.md) | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | Dec 14, 2020 | SESE | | [K202071](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K202071.md) | SURGIPHOR Wound Irrigation System | Orthophor, LLC | Oct 23, 2020 | SESE | | [K192349](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K192349.md) | Bactisure Wound Lavage | Next Science, LLC | Jan 23, 2020 | SESE | | [K161165](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K161165.md) | Next Science Irrigation Solution | Next Science, LLC | Sep 7, 2016 | SESE | | [K143115](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K143115.md) | The VersaJet II Hydrosurgery System | Smith & Nephew, Inc. | Jul 15, 2015 | SESE | | [K113312](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K113312.md) | HY-CHLO(TM)WOUND SCRUB | Patrin Pharma | Aug 21, 2012 | SESE | | [K111313](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K111313.md) | EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE | Alcavis Hdc, LLC | Dec 14, 2011 | SESE | | [K110958](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K110958.md) | VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH | Smith & Nephew, Inc. | Aug 1, 2011 | SESE | | [K090848](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K090848.md) | PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM | Premier Brands of America, Inc. | Jun 17, 2009 | SESE | | [K082858](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH/K082858.md) | EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER | Alcavis International, Inc. | May 27, 2009 | SESE | ## Top Applicants - Irrimax Corporation — 4 clearances - Erbe USA, Inc. — 3 clearances - Hydrocision, Inc. — 3 clearances - Bd — 2 clearances - Howmedica Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FQH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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