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FDA 510(k)

Capillus302, Capillus312, Capillus352

K-Number: K162994 · 2016-11-18

ApplicantCapillus, LLC
Decision Date2016-11-18
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Capillus302, Capillus312, Capillus352 is the device name listed in this FDA 510(k) record. The listed applicant is Capillus, LLC. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K162994. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capillus302, Capillus312, Capillus352?

Capillus302, Capillus312, Capillus352 is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Capillus, LLC. The 510(k) number is K162994.

When did Capillus302, Capillus312, Capillus352 receive FDA 510(k) clearance?

Capillus302, Capillus312, Capillus352 received FDA 510(k) clearance on 2016-11-18, under 510(k) number K162994.

Who is the listed applicant for Capillus302, Capillus312, Capillus352?

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

What is the FDA product code for Capillus302, Capillus312, Capillus352?

The FDA product code for Capillus302, Capillus312, Capillus352 is OAP.

Other records listing Capillus, LLC as applicant

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.

K192012Capillus 112, Capillus 244K163170Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202K153618Capillus202

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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