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FDA 510(k)

KerraContact Ag Perf Advanced Perforated Silver Wound Dressing

K-Number: K182680 · 2018-12-06

ApplicantExciton Technologies, Inc.
Decision Date2018-12-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

KerraContact Ag Perf Advanced Perforated Silver Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Exciton Technologies, Inc.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K182680. 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 KerraContact Ag Perf Advanced Perforated Silver Wound Dressing?

KerraContact Ag Perf Advanced Perforated Silver Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Exciton Technologies, Inc.. The 510(k) number is K182680.

When did KerraContact Ag Perf Advanced Perforated Silver Wound Dressing receive FDA 510(k) clearance?

KerraContact Ag Perf Advanced Perforated Silver Wound Dressing received FDA 510(k) clearance on 2018-12-06, under 510(k) number K182680.

Who is the listed applicant for KerraContact Ag Perf Advanced Perforated Silver Wound Dressing?

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

What is the FDA product code for KerraContact Ag Perf Advanced Perforated Silver Wound Dressing?

The FDA product code for KerraContact Ag Perf Advanced Perforated Silver Wound Dressing 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.

NCT04042259Delayed Primary Closure Using Negative Pressure Wound TherapyACTIVE_NOT_RECRUITINGNCT07066254The Mepilex Cesarean Delivery TrialWITHDRAWNNCT07316192Pelashield™ PainGuard™ vs Restrata® in HS SurgeryRECRUITINGNCT07758855Nanotechnological Silver-Coated Dressing in Diabetic Foot UlcersCOMPLETED

Other records listing Exciton Technologies, Inc. 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.

K162508KerraCel Ag Gelling Fiber Silver Dressing

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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