Cleared Traditional

Pulmonary Cytology Brush

K182927 · Hobbs Medical, Inc. · Anesthesiology

Feb 2020

Decision

473d

Days

Class 2

Risk

About This 510(k) Submission

K182927 is an FDA 510(k) clearance for the Pulmonary Cytology Brush, a Brush, Biopsy, Bronchoscope (non-rigid) (Class II — Special Controls, product code BTG), submitted by Hobbs Medical, Inc. (Stafford Springs, US). The FDA issued a Cleared decision on February 7, 2020, 473 days after receiving the submission on October 22, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K182927 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 22, 2018
Decision Date	February 07, 2020
Days to Decision	473 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement

Device Classification

Product Code	BTG — Brush, Biopsy, Bronchoscope (non-rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).