# K992481: CO2-OP-Pneu Computer, Wisap #7050C, #7050CF, #7050CMF

- 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
The WISAP CO,-Pneu Computer 7050C/7050CF/7050CM/7050CMF may only be used for building up a pneumoperitoneum with CO»-Gas for diagnostic or operative Pelviscopy/lLLaparoscopy.

Source page: https://510kreport.com/device/K992481
Methodology: https://510kreport.com/methodology