K182159 is an FDA 510(k) clearance for the Strome-Blitzer Cytology Balloon. This device is classified as a Esophagoscope (flexible Or Rigid) (Class II - Special Controls, product code EOX).
Submitted by Adn International, LLC (New York, US). The FDA issued a Cleared decision on June 13, 2019, 308 days after receiving the submission on August 9, 2018.
This device falls under the Gastroenterology & Urology 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 | K182159 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2018 |
| Decision Date | June 13, 2019 |
| Days to Decision | 308 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| 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). |