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FDA 510(k)

ENLUXTRA HUMIFIBER WOUND DRESSING

K-Number: K122297 · 2012-08-28

ApplicantBasf Venture Capital America, Inc.
Decision Date2012-08-28
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ENLUXTRA HUMIFIBER WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Basf Venture Capital America, Inc.. It received FDA 510(k) clearance on 2012-08-28 under 510(k) number K122297. 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 ENLUXTRA HUMIFIBER WOUND DRESSING?

ENLUXTRA HUMIFIBER WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2012-08-28. The listed applicant is Basf Venture Capital America, Inc.. The 510(k) number is K122297.

When did ENLUXTRA HUMIFIBER WOUND DRESSING receive FDA 510(k) clearance?

ENLUXTRA HUMIFIBER WOUND DRESSING received FDA 510(k) clearance on 2012-08-28, under 510(k) number K122297.

Who is the listed applicant for ENLUXTRA HUMIFIBER WOUND DRESSING?

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

What is the FDA product code for ENLUXTRA HUMIFIBER WOUND DRESSING?

The FDA product code for ENLUXTRA HUMIFIBER WOUND DRESSING 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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