K200021 is an FDA 510(k) clearance for the Applied Medical Anoscope, a Anoscope And Accessories (Class II — Special Controls, product code FER), submitted by Applied Medical Resources (Rancho Santa, US). The FDA issued a Cleared decision on January 6, 2021, 366 days after receiving the submission on January 6, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K200021 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 06, 2020 |
| Decision Date | January 06, 2021 |
| Days to Decision | 366 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FER — Anoscope And Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine And Perform Procedures Within The Anus And Rectum. |