# K121135: THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-Scope

- Pathway: 510(k) (Traditional)
- Applicant: Thd Spa
- Decided: Jun 1, 2012 after 49 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: 6 generations back to K993738 (2000). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103647: THD Disposable Anoscopes, Proctoscopes and Rectoscopes, Thd Spa (2011) Summary page 2.

## Most influential descendants
- K230439: WellCare Anoscope (2023), 0 descendants of its own

## Indications for use
The family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and, to perform various diagnostic and therapeutic procedures by using additional accessories.

Source page: https://510kreport.com/device/K121135
Methodology: https://510kreport.com/methodology
