K182927 is an FDA 510(k) clearance for the Pulmonary Cytology Brush. This device is classified as 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 FDA review panel. Regulated under 21 CFR 874.4680. 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)..
| 510(k) Number | K182927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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). |