# K982518: Aqua Purator-Biotherm, Wisap Model # 1608

- Pathway: 510(k) (Traditional)
- Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
- Decided: Jan 14, 1999 after 178 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 device is restricted to use by authorized expert personnel/physicians. The WISAP Aqua-Purator Biotherm 1608 is solely destined for operative therapeutical Pelviscopy/Laparoscopy for lavage of the abdominal cavity with physiological saline solution coming from plastic bags up to 5 l volume. The irrigation pressure can be preselected; the preheated liquid in the bag is kept at body temperature.

Source page: https://510kreport.com/device/K982518
Methodology: https://510kreport.com/methodology