# K080780: Anchorage Scope, Model 000003

- Pathway: 510(k) (Traditional)
- Applicant: Epitek, Inc.
- Decided: Jul 30, 2008 after 133 days
- Product code: FBO (Cystourethroscope)
- 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 K912089 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991377: Omnisonics Flexible Fiber Optic Endoscope and Coupler, Omnisonics Medical Technologies (1999) Summary page 1.

## Indications for use
The AnchorageTM Scope is a flexible fiber optic endoscope intended for the visualization of body cavities, organs, canals, and tissues. The Anchorage Scope is designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The Anchorage Scope is indicated for the following applications: Ureteroscopy Bronchoscopy Thoracoscopy Nasopharyngoscopy/Sinuscopy General laparascopy Urology Gynecology

Source page: https://510kreport.com/device/K080780
Methodology: https://510kreport.com/methodology