# K961182: 3D Scope

- Pathway: 510(k) (Traditional)
- Applicant: Oktas
- Decided: Jul 19, 1996 after 115 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 K923160 (1992). 1 ancestor in all.
44 later devices descend from it; 2 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923160: 3DSCOPE, American Surgical Technologies Corp. (1992) Summary page 1.

## Most influential descendants
- K970214: 3 Dimensional Video Endoscope (1997), 42 descendants of its own
- K990635: Vista Stereoscope System (1999), 41 descendants of its own
- K082355: Visionsense Stereoscopic Vision System (2008), 37 descendants of its own
- K141002: VS3 Stereoscopic High Definition Vision System (2014), 36 descendants of its own
- K152204: VS3-IR system (2015), 34 descendants of its own

## Indications for use
The 3D SCOPE™ is designed to aid in visualization for general endoscopic and laparascopic procedures including general thoracic, and as an aid in visualization and examination of the evacuated cardiac chambers.

Source page: https://510kreport.com/device/K961182
Methodology: https://510kreport.com/methodology