Schoelly Cystoscopes/Hysteroscopes and Accessories
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150158 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)
These devices are rigid endoscopes designed for visual examination of the urinary bladder (cystoscopes) and the uterine cavity (hysteroscopes). They fall under the nomenclature category of Hysteroscope (And Accessories) and Cystoscope, enabling direct visualization of internal structures via optical fibers and high-definition imaging. The devices are available in varying diameters, working lengths, and field-of-view configurations to accommodate different clinical procedures and patient anatomies.
Schoelly Cystoscopes and Hysteroscopes are supplied as reusable medical devices, intended for use in sterile operating environments such as outpatient clinics, hospitals, and surgical centers. They are classified under Device Class II and comply with FDA 510(k) clearance and MDR (Medical Device Regulation) requirements. The devices are available in multiple sizes, including 2.9 mm and 4.0 mm diameters, and are paired with compatible accessories to enhance procedural functionality. No MRI safety information is specified, and sterility is achieved through manufacturer-provided reprocessing protocols.
Frequently asked questions
Are these cystoscopes and hysteroscopes designed for single-use or can they be reused after proper cleaning and reprocessing?
The Schoelly Cystoscopes and Hysteroscopes are reusable medical devices, intended for use in sterile environments like outpatient clinics, hospitals, and surgical centers. They must be reprocessed according to the manufacturer’s provided protocols to ensure sterility and safe reuse. No information is provided about single-use versions.
What diameters and working lengths are available for these devices, and how do they accommodate different patient anatomies?
The Schoelly Cystoscopes and Hysteroscopes come in multiple sizes, including 2.9 mm and 4.0 mm diameters, along with varying working lengths and field-of-view configurations. These variations allow clinicians to select the appropriate size for different patient anatomies and procedural requirements, ensuring flexibility for both cystoscopic and hysteroscopic examinations.
How are these devices sterilized, and what kind of reprocessing protocols should be followed?
Sterility for the Schoelly Cystoscopes and Hysteroscopes is achieved through manufacturer-provided reprocessing protocols, which include cleaning and sterilization procedures. Since they are reusable, proper adherence to these protocols is essential to maintain sterility and functionality before each use in sterile environments like operating rooms or clinics.
Are these devices compatible with MRI environments, or should they be avoided in such settings?
The device documentation does not specify MRI safety information, meaning there is no explicit confirmation of MRI compatibility or contraindication. Clinicians should follow standard precautions and consult the manufacturer’s guidelines to ensure safe use in MRI environments.
What regulatory pathways have these devices undergone, and which medical specialty do they primarily support?
The Schoelly Cystoscopes and Hysteroscopes have undergone FDA 510(k) clearance and comply with MDR (Medical Device Regulation) requirements. They are classified under Device Class II and are primarily used in the Obstetrics/Gynecology specialty, as indicated by their advisory committee designation (OB).
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. Sources consulted: Cystoscopes - SCHÖLLY Fiberoptic GmbH - SCHOELLY, Hysteroscopes - SCHÖLLY Fiberoptic GmbH - schoelly.de, Schoelly Cystoscopes/Hysteroscopes and Accessories
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 | K150158 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Schoelly Fiberoptic GmbH
Sources (2)
- FDA 510(k) K150158 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026