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FDA 510(k)

ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN

K-Number: K080795 · 2008-09-03

ApplicantKimberly-Clark Corp.
Decision Date2008-09-03
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corp.. It received FDA 510(k) clearance on 2008-09-03 under 510(k) number K080795. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN?

ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN is a medical device that received FDA 510(k) clearance on 2008-09-03. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K080795.

When did ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN receive FDA 510(k) clearance?

ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN received FDA 510(k) clearance on 2008-09-03, under 510(k) number K080795.

Who is the listed applicant for ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN?

The FDA 510(k) record lists Kimberly-Clark Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN?

The FDA product code for ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN is FYA.

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Related Devices (Code: FYA)

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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