WOM Hysteroflator OP
by W.O.M. GmbH 510(k)
Active
510(k) K922632
Overview
The WOM Hysteroflator OP is a hysteroscopic insufflator designed for distending the uterine cavity during hysteroscopic procedures. It delivers a controlled flow of gas or fluid to provide optimal visualization and working space for diagnostic or therapeutic interventions in the uterus.
This device is supplied as a reusable medical instrument and is classified under FDA regulation 884.1700 as a Class II device. It is intended for use in obstetrics and gynecology settings, with clearance granted under the 510(k) pathway as substantially equivalent to a predicate device. The WOM Hysteroflator OP is regulated under product code HIG and has received FDA clearance (K922632) with a decision date of March 25, 1994.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922632 | Date25 Mar 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HIG
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1700
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from W.O.M. GmbH
Questions
Is the WOM Hysteroflator OP intended for single-use or reusable applications in clinical settings? Why does this matter?
The WOM Hysteroflator OP is designed as a reusable medical instrument, meaning it is meant to be cleaned, disinfected, and reused for multiple procedures. This matters because reusable devices require strict adherence to reprocessing protocols to ensure patient safety, unlike single-use devices which eliminate reprocessing risks entirely. The manufacturer, W.O.M. GmbH, likely provides detailed instructions for cleaning and sterilization to maintain functionality and compliance with regulatory standards.
What types of media (gas or fluid) can the WOM Hysteroflator OP deliver during hysteroscopic procedures, and why is this flexibility important?
The WOM Hysteroflator OP is designed to deliver both gas and fluid to distend the uterine cavity during hysteroscopic procedures. This flexibility is important because different media may be preferred depending on the clinical scenario—gas (e.g., CO₂) provides rapid distension and is often used for diagnostic procedures, while fluid (e.g., glycine or sorbitol) may be used for therapeutic interventions to improve visualization and working space. The device’s versatility accommodates varying procedural needs in obstetrics and gynecology.
How is the WOM Hysteroflator OP regulated, and what does the FDA clearance (K922632) specifically indicate about its safety and effectiveness?
The WOM Hysteroflator OP is classified as a Class II device under FDA regulation 884.1700 and received 510(k) clearance (K922632) on March 25, 1994. This clearance indicates that the device was determined to be substantially equivalent to a predicate device already on the market, meaning the FDA reviewed its design, performance, and safety data to confirm it meets regulatory standards for hysteroscopic insufflators. The clearance does not imply ongoing approval but confirms the device’s compliance with FDA requirements at the time of submission.
What storage or handling considerations should clinicians keep in mind for the WOM Hysteroflator OP, particularly given its reusable nature?
While the device specifications do not explicitly detail storage conditions, reusable medical instruments like the WOM Hysteroflator OP generally require proper cleaning, sterilization, and storage to prevent contamination or damage. Clinicians should follow the manufacturer’s reprocessing guidelines (e.g., autoclave sterilization or chemical disinfection) and store the device in a clean, dry environment away from direct sunlight or extreme temperatures. Proper handling ensures longevity, functionality, and compliance with infection control protocols.