# K993738: Dispos-a-Scope

- Pathway: 510(k) (Traditional)
- Applicant: Dispos-A-Scope
- Decided: Jan 6, 2000 after 63 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
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K020702: O'regan Disposable Anoscope (2002), 13 descendants of its own
- K070913: Self-Light Disposable Anoscope (2007), 11 descendants of its own
- K080132: THD Disposable Anoscope/Proctoscope (2008), 6 descendants of its own
- 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

## Indications for use
The Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy. The Dispos-A-Scope is 11cm long enabling visualization of the ano-rectal canal. The Dispos-A-Scope is constructed totally of a quasi-transparent resin. The resin has passed USP Class VI testing. The scope is designed for one time use and then disposal eliminating the risk of cross infection and nullifying the need for sterilization of the instrument. The Dispos-A-Scope is non-powered. It does not conduct electricity and is non-thermogenic. The Dispos-A-Scope resin is quasi-compliant to external forces and will not crack or craze during normal usage. The Dispos-A-Scope has an ergonomic handle facilitating accurate physician manipulation. The Dispos-A-Scope has an operative port enabling precise isolation of tissue and pathology. The Dispos-A-Scope has a replaceable obturator facilitating device insertion and rotation for precise operative port placement during examination and treatment procedures.

Source page: https://510kreport.com/device/K993738
Methodology: https://510kreport.com/methodology