K143153 is an FDA 510(k) clearance for the EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V. This device is classified as a Duodenoscope And Accessories, Flexible/rigid (Class II - Special Controls, product code FDT).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on January 15, 2016, 438 days after receiving the submission on November 3, 2014.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Examine The Duodenum And To Perform Various Procedures Within The Duodenum. 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 | K143153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2014 |
| Decision Date | January 15, 2016 |
| Days to Decision | 438 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDT — Duodenoscope And Accessories, Flexible/rigid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine The Duodenum And To Perform Various Procedures Within The Duodenum. 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). |