Identity
- Trade Name
- Foot switch double pedal, for SONICBEAT EUDAMEDOlympus FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Footswitches - wired EUDAMEDFoot switch, double pedal, for SONICBEAT FDA UDI
- Model / Reference
- WA91321W EUDAMEDFDA UDI
- Description
- Foot switch, double pedal, for SONICBEAT FDA UDI
Identifiers
- Catalog Number
- WA91321W FDA UDI
- Primary DI / UDI-DI
- 04042761086967 EUDAMEDFDA UDI
- Basic UDI-DI
- 4042761110194Z EUDAMED
- 510(k) Number
- K231777 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010905 RADIOSURGICAL UNITS EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foot-switch, electrical
Olympus by Olympus Winter & Ibe GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Foot-switch, electrical.
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Cleared under the same submission
K231777 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
Sources (2)
- FDA UDI a8e2d452-cb9a-42f1-a509-9115f0f6f841 36 fields · synced Jul 12, 2026
- EUDAMED bf37bd2e-2d98-4c38-825b-d3b33ca924c1 61 fields · synced Jul 12, 2026