# K992513: Therme-Pneu Computer, Wisap #7070C, #7070CF, #7070CM, #7070CMF

- Pathway: 510(k) (Traditional)
- Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
- Decided: Mar 17, 2000 after 235 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This decice is restricted to use by authorized expert personnel / physicians! The WISAP THERME-PNEU Computer 7070C/7070CF/7070CM/7070CMF may only be used for building up a pneumoperitoneum with CO,-Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insuffiation gas to body temperature.

Source page: https://510kreport.com/device/K992513
Methodology: https://510kreport.com/methodology