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FDA 510(k)

Surgical Silver Post Operative Dressing

K-Number: K180634 · 2018-08-07

ApplicantAdvanced Medical Solutions, Ltd.
Decision Date2018-08-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Surgical Silver Post Operative Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2018-08-07 under 510(k) number K180634. 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 Surgical Silver Post Operative Dressing?

Surgical Silver Post Operative Dressing is a medical device that received FDA 510(k) clearance on 2018-08-07. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K180634.

When did Surgical Silver Post Operative Dressing receive FDA 510(k) clearance?

Surgical Silver Post Operative Dressing received FDA 510(k) clearance on 2018-08-07, under 510(k) number K180634.

Who is the listed applicant for Surgical Silver Post Operative Dressing?

The FDA 510(k) record lists Advanced Medical Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Silver Post Operative Dressing?

The FDA product code for Surgical Silver Post Operative Dressing is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing Advanced Medical Solutions, Ltd. 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.

PMA P220024Tissue adhesive internal useK213473Antimicrobial Gelling Fiber Dressing with PHMBK223310Antimicrobial Silicone PHMB Foam Wound DressingK211878LiquiBand XLK210974High Performance Antimicrobial Gelling Fiber with SilverK183570LiquiBand Plus

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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

View on FDA Database →

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

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