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FDA 510(k)

SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S

K-Number: K062212 · 2006-11-21

ApplicantAnacapa Technologies, Inc.
Decision Date2006-11-21
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S is the device name listed in this FDA 510(k) record. The listed applicant is Anacapa Technologies, Inc.. It received FDA 510(k) clearance on 2006-11-21 under 510(k) number K062212. 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 SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S?

SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S is a medical device that received FDA 510(k) clearance on 2006-11-21. The listed applicant is Anacapa Technologies, Inc.. The 510(k) number is K062212.

When did SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S receive FDA 510(k) clearance?

SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S received FDA 510(k) clearance on 2006-11-21, under 510(k) number K062212.

Who is the listed applicant for SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S?

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

What is the FDA product code for SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S?

The FDA product code for SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S 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.

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Other records listing Anacapa 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.

K073547ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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