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FDA 510(k)

NEUROTOLOGY DRAPE, MODEL TBD

K-Number: K002702 · 2000-10-26

ApplicantGyrus Ent LLC
Decision Date2000-10-26
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEUROTOLOGY DRAPE, MODEL TBD is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Ent LLC. It received FDA 510(k) clearance on 2000-10-26 under 510(k) number K002702. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROTOLOGY DRAPE, MODEL TBD?

NEUROTOLOGY DRAPE, MODEL TBD is a medical device that received FDA 510(k) clearance on 2000-10-26. The listed applicant is Gyrus Ent LLC. The 510(k) number is K002702.

When did NEUROTOLOGY DRAPE, MODEL TBD receive FDA 510(k) clearance?

NEUROTOLOGY DRAPE, MODEL TBD received FDA 510(k) clearance on 2000-10-26, under 510(k) number K002702.

Who is the listed applicant for NEUROTOLOGY DRAPE, MODEL TBD?

The FDA 510(k) record lists Gyrus Ent LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROTOLOGY DRAPE, MODEL TBD?

The FDA product code for NEUROTOLOGY DRAPE, MODEL TBD is KKX.

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Related Devices (Code: KKX)

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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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