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FDA 510(k)

SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)

K-Number: K042164 · 2005-06-09

ApplicantMedline Industries, Inc.
Decision Date2005-06-09
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2005-06-09 under 510(k) number K042164. 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 ANTIMICROBIAL WOUND GAUZE (SPONGE)?

SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) is a medical device that received FDA 510(k) clearance on 2005-06-09. The listed applicant is Medline Industries, Inc.. The 510(k) number is K042164.

When did SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) receive FDA 510(k) clearance?

SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) received FDA 510(k) clearance on 2005-06-09, under 510(k) number K042164.

Who is the listed applicant for SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)?

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

What is the FDA product code for SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)?

The FDA product code for SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) is FRO. This falls under the Anesthesiology category.

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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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