FER
- Product code
- FER
- Device name
- Anoscope And Accessories
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 27
FDA classification definition
To examine and perform procedures within the anus and rectum.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250645 | 2025-10-09 | Haemoband Surgical, Ltd. | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX | |
| K242668 | 2024-12-13 | Gastro Concepts, LLC | Gastro Concepts Air Assist | |
| K230439 | 2023-12-22 | Well Care (Wuhan) Medical Technology C | WellCare Anoscope |
Official FDA classification page: FER
Classification and pathway per current FDA publications. Data from openFDA (CC0).