# K970214: 3 Dimensional Video Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Oktas
- Decided: Apr 14, 1997 after 83 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: 2 generations back to K923160 (1992). 4 ancestors in all.
42 later devices descend from it; 1 cites it directly.
0 of 47 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.
- K961182: 3D Scope, Oktas (1996) Summary page 1.
- K946171: Video Endoscope System with Zoom, Oktas (1995) Summary page 1.
- K950985: Zeiss Endolive Stero Endoscope, Carl Zeiss, Inc. (1995). Our OCR of the scanned summary read K950988, FDA’s number for Holter 6000 (Omega Medical Services, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Zeiss EndoLive™ Stereo Endoscope”.

## Most influential descendants
- 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
- K162882: KARL STORZ ICG Imaging System (2017), 32 descendants of its own

## Indications for use
The device is intended for use in all types of endoscopic and endoscopic assisted procedures, including general thoracic and as an aid in visualization of the evacuated cardiac chamber.

Source page: https://510kreport.com/device/K970214
Methodology: https://510kreport.com/methodology