K210485 is an FDA 510(k) clearance for the PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family), a Gastroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FDS), submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on May 13, 2021, 83 days after receiving the submission on February 19, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K210485 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 2021 |
| Decision Date | May 13, 2021 |
| Days to Decision | 83 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). |