# K972488: Ksea Hydromat 263110-20 Pressure Chambers and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: Jan 22, 1998 after 204 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
These instruments are indicated for use by qualified surgeons and physicians to provide pressurized fluid, with a heating option, for irrigation to the surgical site or hydro-dissection during laparoscopic surgical and diagnostic procedures.

Source page: https://510kreport.com/device/K972488
Methodology: https://510kreport.com/methodology