FER

Anoscope And Accessories

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-10-09.

NumberDecision dateApplicantDevice nameSummary
K2506452025-10-09Haemoband Surgical, Ltd.SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUXPDF
K2426682024-12-13Gastro Concepts, LLCGastro Concepts Air AssistPDF
K2304392023-12-22Well Care (Wuhan) Medical Technology CWellCare AnoscopePDF

3 summaries are archived here for direct download.

Official FDA classification page: FER
Classification and pathway per current FDA publications. Data from openFDA (CC0).