# K990662: Disposable Heating Tubing Set #7642HSES

- Pathway: 510(k) (Traditional)
- Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
- Decided: Sep 24, 1999 after 207 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is restricted to use by authorized expert personnel/physicians. The WISAP Disposable Heating Tube 7642HSE is a laparoscopic accessory to be used in connection with the WISAP CO2 insufflator. This system serves for building up a pneumoperitoneum during diagnostic-operative Pelviscopy/Laparoscopy. The insufflation gas is preheated to body temperature by the disposable

Source page: https://510kreport.com/device/K990662
Methodology: https://510kreport.com/methodology