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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)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
27 (all years; only the last 3 years are listed here)

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); SleeveLUX…PDF
K2426682024-12-13Gastro Concepts, LLCGastro Concepts Air AssistPDF
K2304392023-12-22Well Care (Wuhan) Medical Technology C…WellCare 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).