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FDA 510(k)

CRANIOCAP

K-Number: K000861 · 2000-10-30

ApplicantGillette Children'S Specialty Healthcare
Decision Date2000-10-30
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANIOCAP is the device name listed in this FDA 510(k) record. The listed applicant is Gillette Children'S Specialty Healthcare. It received FDA 510(k) clearance on 2000-10-30 under 510(k) number K000861. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRANIOCAP?

CRANIOCAP is a medical device that received FDA 510(k) clearance on 2000-10-30. The listed applicant is Gillette Children'S Specialty Healthcare. The 510(k) number is K000861.

When did CRANIOCAP receive FDA 510(k) clearance?

CRANIOCAP received FDA 510(k) clearance on 2000-10-30, under 510(k) number K000861.

Who is the listed applicant for CRANIOCAP?

The FDA 510(k) record lists Gillette Children'S Specialty Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRANIOCAP?

The FDA product code for CRANIOCAP is MVA.

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Related Devices (Code: MVA)

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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