# K024095: Modification to Vision Sciences Endosheath System

- Pathway: 510(k) (Special)
- Applicant: Vision-Sciences, Inc.
- Decided: Jan 9, 2003 after 28 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: 4 generations back to K921244 (1992). 11 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 43 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
- K072073: Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor (2007), 29 descendants of its own
- K080622: Entity Nasoview Led Nasopharyngoscope, Model 006105 (2008), 15 descendants of its own
- K091829: PLS Portable Light Source (2009), 9 descendants of its own
- K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor (2011), 7 descendants of its own
- K130503: Pathassist Led Light Fiber (2013), 6 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 cords and/or nasal passages.

Source page: https://510kreport.com/device/K024095
Methodology: https://510kreport.com/methodology