# K013838: Ksea Clearvision Lens Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jan 16, 2002 after 58 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Endo-suction/irrigation pump: named in the summary without a submission number

## Most influential descendants
- K072410: Ksea Clearvision II, Model 40334120 (2008), 4 descendants of its own
- K180735: Endomat Select (2018), 2 descendants of its own
- K201355: Endomat Select, IBS Shaver Software, License (2020), 1 descendant of its own
- K261706: Endomat Select (UP220) (2026), 0 descendants of its own
- K261544: Hydro Irrigation System (2026), 0 descendants of its own

## Indications for use
The KSEA Clearvision® is a lens irrigation system for cleaning the lens and maintaining clear visualization without removing the scope from the surgical site during sinus surgery.

Source page: https://510kreport.com/device/K013838
Methodology: https://510kreport.com/methodology