K152794 is an FDA 510(k) clearance for the Cytosponge Cell Collection Device. This device is classified as a Esophagoscope (flexible Or Rigid) (Class II - Special Controls, product code EOX).
Submitted by Covidien, LLC (Mansfield, US). The FDA issued a Cleared decision on April 12, 2016, 197 days after receiving the submission on September 28, 2015.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4710. 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 | K152794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2015 |
| Decision Date | April 12, 2016 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EOX — Esophagoscope (flexible Or Rigid) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4710 |
| 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). |