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FDA 510(k)

KerraCel Ag Gelling Fiber Silver Dressing

K-Number: K162508 · 2017-02-13

ApplicantExciton Technologies, Inc.
Decision Date2017-02-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

KerraCel Ag Gelling Fiber Silver 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 2017-02-13 under 510(k) number K162508. 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 KerraCel Ag Gelling Fiber Silver Dressing?

KerraCel Ag Gelling Fiber Silver Dressing is a medical device that received FDA 510(k) clearance on 2017-02-13. The listed applicant is Exciton Technologies, Inc.. The 510(k) number is K162508.

When did KerraCel Ag Gelling Fiber Silver Dressing receive FDA 510(k) clearance?

KerraCel Ag Gelling Fiber Silver Dressing received FDA 510(k) clearance on 2017-02-13, under 510(k) number K162508.

Who is the listed applicant for KerraCel Ag Gelling Fiber Silver 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 KerraCel Ag Gelling Fiber Silver Dressing?

The FDA product code for KerraCel Ag Gelling Fiber Silver Dressing is FRO. This falls under the Anesthesiology category.

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.

K182680KerraContact Ag Perf Advanced Perforated Silver Wound 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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