# K031786: Tne-2000 Esophagoscope with Ecs-D Endosheath System

- Pathway: 510(k) (Traditional)
- Applicant: Vision-Sciences, Inc.
- Decided: Aug 5, 2003 after 56 days
- Product code: EOX (Esophagoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921244 (1992). 11 ancestors in all.
92 later devices descend from it; 8 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990354: Endosheath, Vision-Sciences, Inc. (1999) Summary page 1.
- K012543: Vision Sciences Endosheath System, Vision-Sciences, Inc. (2002)
- K021344: B-F200 Bronchoscope with BSS-F21 Endosheath System, Vision-Sciences, Inc. (2002)

## Most influential descendants
- K072088: Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable Endosheath Systems (2007), 70 descendants of its own
- K091768: Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor & Accessories (2009), 66 descendants of its own
- K130845: Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview (2013), 64 descendants of its own
- K161656: Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor (2016), 40 descendants of its own
- K173727: Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor (2018), 39 descendants of its own

## Indications for use
The Vision-Sciences Trans-Nasal Esophagoscope with Endosheath® System is indicated for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The System may also be used to assist intubation.

Source page: https://510kreport.com/device/K031786
Methodology: https://510kreport.com/methodology