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FDA 510(k)

HISTOBRUSH

K-Number: K111681 · 2012-01-19

ApplicantPuritan Medical Products Company, LLC
Decision Date2012-01-19
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HISTOBRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Medical Products Company, LLC. It received FDA 510(k) clearance on 2012-01-19 under 510(k) number K111681. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISTOBRUSH?

HISTOBRUSH is a medical device that received FDA 510(k) clearance on 2012-01-19. The listed applicant is Puritan Medical Products Company, LLC. The 510(k) number is K111681.

When did HISTOBRUSH receive FDA 510(k) clearance?

HISTOBRUSH received FDA 510(k) clearance on 2012-01-19, under 510(k) number K111681.

Who is the listed applicant for HISTOBRUSH?

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

What is the FDA product code for HISTOBRUSH?

The FDA product code for HISTOBRUSH is HHT.

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Related Devices (Code: HHT)

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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