K250645 is an FDA 510(k) clearance for the SleeveLUX 24 Anoscope/Proctoscope (P2001). This device is classified as a Anoscope And Accessories (Class II - Special Controls, product code FER).
Submitted by Haemoband Surgical, Ltd. (Belfast, GB). The FDA issued a Cleared decision on October 9, 2025, 219 days after receiving the submission on March 4, 2025.
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 | K250645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2025 |
| Decision Date | October 09, 2025 |
| Days to Decision | 219 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. |