# K230439: WellCare Anoscope

- Pathway: 510(k) (Traditional)
- Applicant: Well Care (Wuhan) Medical Technology Co., Ltd.
- Decided: Dec 22, 2023 after 304 days
- Product code: FER (Anoscope And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K993738 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121135: THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-Scope, Thd Spa (2012) Summary page 5.

## Indications for use
WellCare Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.

Source page: https://510kreport.com/device/K230439
Methodology: https://510kreport.com/methodology