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FDA 510(k)

KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100

K-Number: K093115 · 2010-03-19

ApplicantKimberly-Clark Corp.
Decision Date2010-03-19
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 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 2010-03-19 under 510(k) number K093115. 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 KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100?

KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 is a medical device that received FDA 510(k) clearance on 2010-03-19. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K093115.

When did KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 receive FDA 510(k) clearance?

KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 received FDA 510(k) clearance on 2010-03-19, under 510(k) number K093115.

Who is the listed applicant for KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100?

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 KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100?

The FDA product code for KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 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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