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FDA 510(k)

Clyra Wound Irrigation Solution

K-Number: K181428 · 2019-09-20

ApplicantClyra Medical Technologies, Inc.
Decision Date2019-09-20
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Clyra Wound Irrigation Solution is the device name listed in this FDA 510(k) record. The listed applicant is Clyra Medical Technologies, Inc.. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K181428. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clyra Wound Irrigation Solution?

Clyra Wound Irrigation Solution is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Clyra Medical Technologies, Inc.. The 510(k) number is K181428.

When did Clyra Wound Irrigation Solution receive FDA 510(k) clearance?

Clyra Wound Irrigation Solution received FDA 510(k) clearance on 2019-09-20, under 510(k) number K181428.

Who is the listed applicant for Clyra Wound Irrigation Solution?

The FDA 510(k) record lists Clyra Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clyra Wound Irrigation Solution?

The FDA product code for Clyra Wound Irrigation Solution is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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.

NCT06339203Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)RECRUITINGNCT06439953Irrisept Solution for Instrumented Spine SurgeryRECRUITINGNCT07667036Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative StudyNOT_YET_RECRUITING

Related Devices (Code: FRO)

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.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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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