# K080852: Ksea Electronic CO2 Endoflator LC, Model 26430320-1

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Mar 30, 2009 after 369 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
Longest line of descent: 1 generation back to K962863 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963423: Ksea CO2 Endoflator, Karl Storz Endoscopy (1997) Summary page 1.
- K962863: Karl Storz Model 264305-20 Electronic Endoflator, KARL STORZ Endoscopy-America, Inc. (1996) Summary page 1.

## Indications for use
The KSEA Electronic C02 ENDOFLATOR LC provides C02 gas distention of the abdomen (pneumoperitoneum) for diagnostic or operative laparoscopy. See the instruction manual for your laparoscope for special indications for use.

Source page: https://510kreport.com/device/K080852
Methodology: https://510kreport.com/methodology