# K983889: Hys-Surgiflator 150P

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine GmbH
- Decided: Jan 14, 1999 after 73 days
- Product code: HIG (Insufflator, Hysteroscopic)
- Device class: 2
- Regulation: 21 CFR 884.1700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922632 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922632: Wom Hysteroflator OP, W.O.M. GmbH (1994) Summary page 1.

## Indications for use
The HYS-Surgiflator 150P is a hysteroscopic insufflator intended to distend the uterus by fillng the uterine cavity with a gas to facilitate viewing with a hysteroscope (21 C.F.R. § 884.1700).

Source page: https://510kreport.com/device/K983889
Methodology: https://510kreport.com/methodology