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FDA 510(k)

SALINE WOUND WASH

K-Number: K112666 · 2012-04-20

ApplicantNanoplas, Inc.
Decision Date2012-04-20
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SALINE WOUND WASH is the device name listed in this FDA 510(k) record. The listed applicant is Nanoplas, Inc.. It received FDA 510(k) clearance on 2012-04-20 under 510(k) number K112666. 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 SALINE WOUND WASH?

SALINE WOUND WASH is a medical device that received FDA 510(k) clearance on 2012-04-20. The listed applicant is Nanoplas, Inc.. The 510(k) number is K112666.

When did SALINE WOUND WASH receive FDA 510(k) clearance?

SALINE WOUND WASH received FDA 510(k) clearance on 2012-04-20, under 510(k) number K112666.

Who is the listed applicant for SALINE WOUND WASH?

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

What is the FDA product code for SALINE WOUND WASH?

The FDA product code for SALINE WOUND WASH is FRO. This falls under the Anesthesiology category.

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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.

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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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