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510(k) K192349

Device
Bactisure Wound Lavage
Applicant
Next Science, LLC
510(k) number
K192349
Product code
FQH  
Decision
Substantially Equivalent (SESE)
Decision date
2020-01-23
Date received
2019-08-29
Regulation
880.5475
Classification name
Lavage, Jet
Medical specialty
General Hospital
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jeanne Lee
Address
10550 Deerwood Park Blvd., Suite 300 Jacksonsonville FL US 32256 32256

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FQH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)2026-02-25
K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd2026-02-20
K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH2023-06-15
K220759Armis VeriCyn Wound WashArmis Biopharma, Inc.2023-05-25
K220964VERSAJET Hydrosurgery System (III)Smith & Nephew Medical Limited2023-05-16
K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd2022-10-14
K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation2022-09-22
K210987IRRIGO Wound Wash Jet SystemInopro, Inc.2022-05-31
K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company2022-03-23
K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation2021-05-28
K202222Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation2020-12-14
K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC2020-10-23
K161165Next Science Irrigation SolutionNext Science, LLC2016-09-07
K143115The VersaJet II Hydrosurgery SystemSmith & Nephew, Inc.2015-07-15
K113312HY-CHLO(TM)WOUND SCRUBPatrin Pharma2012-08-21

Legacy Summary#

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FDA Review#

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