# K012543: Vision Sciences Endosheath System

- Pathway: 510(k) (Traditional)
- Applicant: Vision-Sciences, Inc.
- Decided: Jul 15, 2002 after 342 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: 3 generations back to K921244 (1992). 6 ancestors in all.
157 later devices descend from it; 4 cite it directly.
0 of 164 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.
- (no number) Thermometer Covers: named in the summary without a submission number
- (no number) Transesophageal Ultrasound Probe Covers: named in the summary without a submission number

## Most influential descendants
- K031786: Tne-2000 Esophagoscope with Ecs-D Endosheath System (2003), 92 descendants of its own
- 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

## Indications for use
The EndoSheathB System provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.

Source page: https://510kreport.com/device/K012543
Methodology: https://510kreport.com/methodology