K181763 is an FDA 510(k) clearance for the FUJIFILM Ultrasonic Endoscope. This device is classified as a Gastroscope And Accessories, Flexible/rigid (Class II - Special Controls, product code FDS).
Submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on July 27, 2018, 24 days after receiving the submission on July 3, 2018.
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 | K181763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2018 |
| Decision Date | July 27, 2018 |
| Days to Decision | 24 days |
| Submission Type | Special |
| 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). |