Schoelly Cystoscopes/Hysteroscopes and Accessories
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201970 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) as classified under FDA nomenclature. It is designed for diagnostic and therapeutic procedures within the urinary bladder (cystoscopy) and uterine cavity (hysteroscopy), enabling visual inspection and intervention using optical fiber technology. The system includes rigid and flexible scopes, along with complementary accessories for enhanced functionality.
The device is supplied as a reusable medical instrument, intended for use in clinical settings such as obstetrics and gynecology. It is regulated under the FDA 510(k) pathway with Substantial Equivalence determination (K201970) and MDR compliance in the EU. Models are identified by specific FEI numbers (e.g., 3015139943) and are classified as Class II devices. Sterilization and maintenance protocols must adhere to manufacturer guidelines to ensure safety and performance.
Frequently asked questions
Are these cystoscopes and hysteroscopes designed for single-use or reusable applications in clinical settings?
These devices are explicitly supplied as reusable medical instruments, intended for repeated use in clinical settings like obstetrics and gynecology. Proper sterilization and maintenance per manufacturer guidelines are required to ensure safety and performance.
What regulatory pathways have these devices followed for FDA and EU approval?
The devices were cleared via the FDA 510(k) pathway with a Substantial Equivalence (SE) determination under K201970, classified as Class II. In the EU, they comply with MDR (Medical Device Regulation) requirements, ensuring alignment with both regulatory frameworks.
How do I identify the specific model of a Schoelly cystoscope or hysteroscope in my inventory?
Each model is uniquely identified by an FEI number (e.g., 3015139943, 3011459664). These numbers appear in the device’s regulatory records and can be cross-referenced with the manufacturer’s documentation to confirm the exact model and specifications.
Are these devices intended for both diagnostic and therapeutic procedures, and if so, where are they primarily used?
Yes, these devices are designed for both diagnostic and therapeutic procedures within the urinary bladder (cystoscopy) and uterine cavity (hysteroscopy). They are primarily used in obstetrics and gynecology settings, enabling visual inspection and intervention via optical fiber technology.
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 | K201970 | Class II | Active |
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Manufacturer
- Manufacturer
- Schoelly Fiberoptic GmbH
Sources (2)
- FDA 510(k) K201970 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026