# K990354: Endosheath

- Pathway: 510(k) (Special)
- Applicant: Vision-Sciences, Inc.
- Decided: Mar 31, 1999 after 54 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: 2 generations back to K921244 (1992). 5 ancestors in all.
180 later devices descend from it; 12 cite it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950809: Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-Laryngoscopes, Vision-Sciences, Inc. (1996) Summary page 1.
- K961591: Disposable Endosheath for E-F100 Flexible Nasopharyngoscope, Vision-Sciences, Inc. (1996) Summary page 1.
- K933247: Protective Sheath for Flexible Nasophary/Larygnos, Vision-Sciences, Inc. (1993) Summary page 1.
- K925421: Endosheath, Vision-Sciences, Inc. (1993) Summary page 1.
- K921244: Disposable Protective Sheath, Vision-Sciences, Inc. (1992) Summary page 1.

## Most influential descendants
- K012543: Vision Sciences Endosheath System (2002), 157 descendants of its own
- K021344: B-F200 Bronchoscope with BSS-F21 Endosheath System (2002), 157 descendants of its own
- 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

## Indications for use
The EndoSheath® 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/K990354
Methodology: https://510kreport.com/methodology