# K990334: Ksea Endoscope Holder

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Mar 22, 1999 after 47 days
- Product code: OCV (Endoscope Holder)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
38 later devices descend from it; 5 cite it directly.
0 of 39 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 no predicate by number.

## Most influential descendants
- K051979: Ors Model 6000 Endoscope Holder (2005), 25 descendants of its own
- K062779: Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp) (2006), 23 descendants of its own
- K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 (2008), 16 descendants of its own
- K992006: Neuroview Instrument Holder, Model 300-33 (1999), 10 descendants of its own
- K050051: Armand Endoscope Holder (2005), 9 descendants of its own

## Indications for use
This instrument is a manually operated surgical devices intended for use by qualified surgeons for holding rigid and flexible endoscopes during diagnostic and therapeutic neurologic procedures.

Source page: https://510kreport.com/device/K990334
Methodology: https://510kreport.com/methodology