# K042780: Neoscope - Endoscopic Diagnostic & Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Prosurg, Inc.
- Decided: Feb 3, 2005 after 120 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
Neoscope TM - Endoscopic Diagnostic and Treatment System is intended for cystoscopic, hysteroscopic laparoscopic, resectoscopic and endoscopic treatment of urological, gynecological, gasteroenterological disorders and diseases of prostate, bladder, urethra, uterine cavity, stomach, GI, urinary tract and reproductive organs using biomaterials, laser & RF devices, tissue ablative and augmenting agents, microsurgical instrument and endoscopic accessories.

Source page: https://510kreport.com/device/K042780
Methodology: https://510kreport.com/methodology