HSW Hysteroscope and Accessories
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K952186 FDA 510(k)
- FDA Product Code
- HIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1690 FDA 510(k)
- Regulation Number
- 884.1690 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Hysteroscope (and Accessories), a rigid or flexible endoscope used to visually inspect the interior of the uterus. Hysterosopes are designed for diagnostic and therapeutic procedures in obstetrics and gynecology, enabling direct visualization of the uterine cavity, cervical canal, and fallopian ostia. They are often paired with accessories such as sheaths, distension media, and biopsy tools to facilitate interventions like tissue sampling or polyp removal.
The HSW Hysteroscope and Accessories are supplied as reusable medical devices, intended for use in clinical settings such as hospitals and outpatient clinics. They are classified as Class II devices under FDA regulations and comply with FDA 510K and MDR authorizations. Multiple model references are listed, indicating variations in size, design, and functionality, though specific sterility and MRI safety details are not provided in the data. Storage and handling follow standard aseptic protocols for reusable endoscopes.
Frequently asked questions
Are the HSW hysteroscope models reusable or single-use, and what does this mean for my clinical workflow?
The HSW hysterosopes and accessories are designed as reusable medical devices, meaning they are intended for repeated use after proper cleaning, disinfection, and sterilization. This requires adherence to strict aseptic protocols, including dedicated reprocessing workflows in your facility. Reusability allows for cost efficiency and reduces waste, but it also demands compliance with regulatory guidelines for endoscope reprocessing to ensure patient safety and device integrity.
What types of procedures can these hysterosopes be used for, and how do they differ from other diagnostic tools?
These hysterosopes are used for visual inspection of the uterus, cervical canal, and fallopian ostia, enabling both diagnostic and therapeutic procedures in obstetrics and gynecology. Unlike ultrasound or MRI, they provide direct visualization, allowing clinicians to identify abnormalities like polyps, fibroids, or structural anomalies while also facilitating interventions such as tissue sampling or polyp removal. Their rigid or flexible design accommodates varying clinical needs, from outpatient evaluations to more complex therapeutic applications.
How many different model references are available, and what does this variety imply for my practice?
The HSW hysteroscope lineup includes multiple model references (over 100 unique FEI/registration numbers listed), indicating variations in size, design, and functionality. This diversity allows clinicians to select the appropriate scope for specific patient anatomies or procedural requirements—such as narrower channels for biopsy tools or specific angles for better visualization. The range ensures compatibility with a broad spectrum of clinical scenarios, from routine diagnostic evaluations to specialized therapeutic cases.
What regulatory pathways have these devices undergone, and how does this affect their use in my facility?
The HSW hysterosopes and accessories are authorized under FDA 510(k) clearance and comply with MDR (Medical Device Regulation) standards. This means they meet U.S. and EU regulatory requirements for safety and performance, ensuring they can be legally used in clinical settings where these pathways apply. While the data does not specify MRI safety or sterility guarantees, compliance with these frameworks confirms rigorous evaluation by regulatory bodies, though your facility must still follow manufacturer reprocessing instructions and local guidelines for safe use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K952186 | Class II | Active |
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Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
Sources (2)
- FDA 510(k) K952186 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026