# K254299: CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Sep 15, 2026 after 258 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: 1 generation back to K943816 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943816: Trocars,Cannulae, Sheaths, Karl Storz Endoskop GmbH (1994) Summary page 5.

## Indications for use
The irrigation sheaths are intended to provide irrigation in endoscopic diagnosis and surgical interventions in the nasal cavity and paranasal sinuses.

Source page: https://510kreport.com/device/K254299
Methodology: https://510kreport.com/methodology