FDA 510(k)

Pulmonary Cytology Brush

K-Number: K182927 · 2020-02-07

Decision Date2020-02-07

Product CodeBTG

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Pulmonary Cytology Brush is the device name listed in this FDA 510(k) record. The listed applicant is Hobbs Medical, Inc.. It received FDA 510(k) clearance on 2020-02-07 under 510(k) number K182927. The device is classified under product code BTG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pulmonary Cytology Brush?

Pulmonary Cytology Brush is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Hobbs Medical, Inc.. The 510(k) number is K182927.

When did Pulmonary Cytology Brush receive FDA 510(k) clearance?

Pulmonary Cytology Brush received FDA 510(k) clearance on 2020-02-07, under 510(k) number K182927.

Who is the listed applicant for Pulmonary Cytology Brush?

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

What is the FDA product code for Pulmonary Cytology Brush?

The FDA product code for Pulmonary Cytology Brush is BTG.

Other records listing Hobbs Medical, Inc. 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.

K241874Aspiration Catheter (2189)

Related Devices (Code: BTG)

K251279Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation K190293Single Use Cytology Brush BC-205DOlympus Medical Systems Corp.

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.