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FDA 510(k)

Bactisure Wound Lavage

K-Number: K192349 · 2020-01-23

ApplicantNext Science, LLC
Decision Date2020-01-23
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Bactisure Wound Lavage is the device name listed in this FDA 510(k) record. The listed applicant is Next Science, LLC. It received FDA 510(k) clearance on 2020-01-23 under 510(k) 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. The listed applicant is Next Science, LLC. The 510(k) number is K192349.

When did Bactisure Wound Lavage receive FDA 510(k) clearance?

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

Who is the listed applicant for Bactisure Wound Lavage?

The FDA 510(k) record lists Next Science, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bactisure Wound Lavage?

The FDA product code for Bactisure Wound Lavage is FQH.

Other records listing Next Science, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203446TorrentX Wound WashK203835MIS SolutionK163188Next Science Wound Gel (Rx)K161165Next Science Irrigation Solution

Related Devices (Code: FQH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)BdK231023ERBEJET® 2 SystemErbe Elektromedizin GmbHK220759Armis VeriCyn Wound WashArmis Biopharma, Inc.K220964VERSAJET Hydrosurgery System (III)Smith & Nephew Medical LimitedK221504BD Surgiphor™ Antimicrobial Irrigation SystemBd

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.

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