# K963423: Ksea CO2 Endoflator

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: May 27, 1997 after 270 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K080852: Ksea Electronic CO2 Endoflator LC, Model 26430320-1 (2009), 0 descendants of its own

## Indications for use
These instruments are intended for use by qualified surgeons and provide gas insufflation designed for • diagnostic laparoscopic procedures, and • laparoscopic sterilization procedures.

Source page: https://510kreport.com/device/K963423
Methodology: https://510kreport.com/methodology