K221551 is an FDA 510(k) clearance for the FUJIFILM Endoscope Model EI-740D/S. This device is classified as a Gastroscope And Accessories, Flexible/rigid (Class II - Special Controls, product code FDS).
Submitted by Fujifilm Corporaton (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on January 27, 2023, 241 days after receiving the submission on May 31, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data 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 | K221551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2022 |
| Decision Date | January 27, 2023 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDS — Gastroscope And Accessories, Flexible/rigid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data 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). |