# K173489: GYN-Pump PH304

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine GmbH
- Decided: Mar 28, 2018 after 135 days
- Product code: HIG (Insufflator, Hysteroscopic)
- Device class: 2
- Regulation: 21 CFR 884.1700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K950035 (1996). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112642: Aquilex Fluid Control System H112, W.O.M. World of Medicine AG (2012) Summary page 5.
- K163320: LAP-Pump PP110, W.O.M. World of Medicine GmbH (2017) Summary page 5.

## Recalls of this device
- Jun 18, 2021 · Class II · Z-2561-2021: When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outfl

## Indications for use
The GYN-Pump PH304 is a combined suction and irrigation pump for use in hysteroscopic and laparoscopic interventions. During diagnostic and operative hysteroscopy, the GYN-Pump PH304 is intended to provide liquid distension of the uterus and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. During diagnostic and therapeutic laparoscopic procedures, the GYN-Pump PH304 is intended to irrigate fluid into and remove fluid from the abdominal cavity.

Source page: https://510kreport.com/device/K173489
Methodology: https://510kreport.com/methodology