WellCare Anoscope— 510(k) K230439

Name: FDA 510(k) clearance K230439
Creator: U.S. Food and Drug Administration
Published: 2023-12-22

Substantially Equivalent

Well Care (Wuhan) Medical Technology Co., Ltd.

FDA 510(k) clearance K230439 for WellCare Anoscope, Substantially Equivalent on 2023-12-22. Applicant: Well Care (Wuhan) Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Well Care (Wuhan) Medical Technology Co., Ltd.
Product code: Code FER
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-02-21
Decision date: 2023-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuhan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FER

view all

K250645 — SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)2025-10-09
K242668 — Gastro Concepts Air Assist2024-12-13
K200021 — Applied Medical Anoscope2021-01-06
K171701 — GelPOINT Path Transanal Access Platform2017-07-20
K133393 — GELPOINT PATH TRANSANAL ACCESS PLATFORM2014-01-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.