# K152619: Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)

- Pathway: 510(k) (Traditional)
- Applicant: Prosurg, Inc.
- Decided: Apr 29, 2016 after 228 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 1 generation back to K042780 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042780: Neoscope - Endoscopic Diagnostic & Treatment System, Prosurg, Inc. (2005) Summary page 4.
- K120766: Endoscopic Diagnostic & Treatment System (Modification), Prosurg, Inc. (2012) Summary page 4.

## Indications for use
The Prosurg’s Neoscope 3D™ -3D Digital Video Endoscopic System ( Rigid & Flexible) is intended to provide “Real -Time” 3D images and video to surgeons for endoscopic examination, diagnosis and treatment for Minimally Invasive surgical Procedures within Abdominal and Female Reproductive organs, using surgical devices and accessories.

Source page: https://510kreport.com/device/K152619
Methodology: https://510kreport.com/methodology