# K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor

- Pathway: 510(k) (Traditional)
- Applicant: Vision-Sciences, Inc.
- Decided: May 18, 2011 after 238 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K833587 (1983). 55 ancestors in all.
7 later devices descend from it; 5 cite 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)
- K072073: Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor, Vision-Sciences, Inc. (2007) Summary page 1.
- K093717: C-Mor Visualization Device, Axis Surgical Technologies, Inc. (2010) Summary page 1.
- K072879: Innervue Diagnostic Scope System, Biomet Orthopedics, Inc. (2008) Summary page 1.
- K043395: Smith & Nephew Videoarthroscope, Smith & Nephew, Inc. (2005) Summary page 1.
- K081051: Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope, Spine View, Inc. (2008) Summary page 1.

## Most influential descendants
- K150776: Medrobotics Flex System (2015), 1 descendant of its own
- K123359: OVS1 Video System (2012), 1 descendant of its own
- K181292: PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor (2018), 0 descendants of its own
- K170453: Medrobotics Flex Robotic System (2017), 0 descendants of its own
- K152513: 8X-10-XXXX Camera System (2015), 0 descendants of its own

## Indications for use
The flexible ENT-5000 Video ENT Scope with EndoSheath® Technology is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages; and for use in diagnostic arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The digital video processor is intended for use with the VSi flexible video scope.

Source page: https://510kreport.com/device/K102733
Methodology: https://510kreport.com/methodology