K230439 is an FDA 510(k) clearance for the WellCare Anoscope. This device is classified as a Anoscope And Accessories (Class II - Special Controls, product code FER).
Submitted by Well Care (Wuhan) Medical Technology Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on December 22, 2023, 304 days after receiving the submission on February 21, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Examine And Perform Procedures Within The Anus And Rectum..
| 510(k) Number | K230439 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2023 |
| Decision Date | December 22, 2023 |
| Days to Decision | 304 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. |