FDA 510(k)

Bactisure Wound Lavage

K-Number: K192349 · 2020-01-23

Decision Date2020-01-23

Product CodeFQH

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Bactisure Wound Lavage is a medical device manufactured by Next Science, LLC. It received FDA 510(k) clearance on 2020-01-23 under approval number K192349. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bactisure Wound Lavage?

Bactisure Wound Lavage is a medical device that received FDA 510(k) clearance on 2020-01-23. It is manufactured by Next Science, LLC. The 510(k) number is K192349.

When was Bactisure Wound Lavage approved by the FDA?

Bactisure Wound Lavage received FDA 510(k) clearance on 2020-01-23, under approval number K192349.

What company makes Bactisure Wound Lavage?

Bactisure Wound Lavage is manufactured by Next Science, LLC.

What is the FDA product code for Bactisure Wound Lavage?

The FDA product code for Bactisure Wound Lavage is FQH.

Other Devices by Next Science, LLC

K161165Next Science Irrigation Solution K163188Next Science Wound Gel (Rx) K203446TorrentX Wound Wash K203835MIS Solution

Related Devices (Code: FQH)

K161165Next Science Irrigation SolutionNext Science, LLC K202222Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation K221504BD Surgiphor Antimicrobial Irrigation SystemBd K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.