K130357 is an FDA 510(k) clearance for the SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH. This device is classified as a Brush, Biopsy, Bronchoscope (non-rigid) (Class II - Special Controls, product code BTG).
Submitted by Covidien, LLC (Plymouth, US). The FDA issued a Cleared decision on November 6, 2013, 266 days after receiving the submission on February 13, 2013.
This device falls under the Ear, Nose, Throat 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 | K130357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2013 |
| Decision Date | November 06, 2013 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| 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). |