# K080132: THD Disposable Anoscope/Proctoscope

- Pathway: 510(k) (Traditional)
- Applicant: Thd Spa
- Decided: Apr 9, 2008 after 82 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: 3 generations back to K993738 (2000). 7 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070913: Self-Light Disposable Anoscope, Sapimed S.P.A. (2007) Summary page 2.
- K070915: Sapimed Disposable Sigmoidoscope, Sapimed S.P.A. (2007) Summary page 2.

## Most influential descendants
- K091490: Family of THD Disposable Anoscopes/Proctoscopes/Rectoscopes (2009), 4 descendants of its own
- K103647: THD Disposable Anoscopes, Proctoscopes and Rectoscopes (2011), 3 descendants of its own
- K121135: THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-Scope (2012), 1 descendant of its own
- K230439: WellCare Anoscope (2023), 0 descendants of its own
- K133687: THD N-Ano Anoscope (2013), 0 descendants of its own

## Indications for use
The family of "THD disposable Anoscope/Proctoscope" is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K080132
Methodology: https://510kreport.com/methodology