# K123359: OVS1 Video System

- Pathway: 510(k) (Traditional)
- Applicant: Olive Medical Corp.
- Decided: Dec 19, 2012 after 49 days
- Product code: FCW (Light Source, Fiberoptic, Routine)
- 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: 8 generations back to K833587 (1983). 61 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070716: Image 1 Video Imaging System with Optional Insufflators Control, KARL STORZ Endoscopy-America, Inc. (2007) Summary page 1.
- K072879: Innervue Diagnostic Scope System, Biomet Orthopedics, Inc. (2008) Summary page 1.
- K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor, Vision-Sciences, Inc. (2011) Summary page 1.
- K093792: Led Light Source, Sunoptic Technologies, LLC (2010) Summary page 1.
- K961074: Lightsource or Illuminator, Cuda Products Co. (1996) Summary page 2.
- (no number) Tele Pack X: named in the summary without a submission number

## Most influential descendants
- K152513: 8X-10-XXXX Camera System (2015), 0 descendants of its own

## Indications for use
The OVS 1 Video System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The OVS 1 Video System is indicated for use with a compatible Olive Medical Camera Head and other accessory devices including an endoscope, optical coupler, and light cable

Source page: https://510kreport.com/device/K123359
Methodology: https://510kreport.com/methodology