# K120766: Endoscopic Diagnostic & Treatment System (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Prosurg, Inc.
- Decided: Sep 11, 2012 after 182 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K152619: Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) (2016), 0 descendants of its own

## Indications for use
The Prosurg's NeoScope (Cystourethroscope / Cystoureteroscope / Cystonephroscope) video Endoscope and Video Capture Digital Video System (which includes the Digital Module) is intended for use to examine body cavities, hollow organs and canals in the body in the urinary tract, and can be percutaneously to examine the interior of the kidney and using additional accessories can be used to perform various diagnostic and therapeutic procedures. The Prosurg's Neoscope (Hysteroscope) Digital Video System (which includes the Digital Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Gynecological tract, and can be percutaneously to examine the interior of the uterus and using additional accessories can be used to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K120766
Methodology: https://510kreport.com/methodology