Identity
- Trade Name
- PowerWire Pro Radiofrequency Guidewire Kit FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- PowerWire Pro RF Guidewire; RFP-100A Connector Cable FDA UDI
- Model / Reference
- PSK35-250-12-6A-40 FDA UDI
- Description
- PowerWire Pro RF Guidewire; RFP-100A Connector Cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540299000402 FDA UDI
- 510(k) Number
- K232562 FDA UDI
- FDA Product Code
- DSA FDA UDIPDU FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2900 FDA UDI870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic electrosurgical electrode, monopolar, single-use
PowerWire Pro Radiofrequency Guidewire Kit by Baylis Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K232562 also covers:
- PowerWire Pro Radiofrequency Guidewire Kit — Baylis Medical Technologies Inc
- PowerWire Pro Radiofrequency Guidewire Kit — Baylis Medical Technologies Inc
- PowerWire Pro Radiofrequency Guidewire Kit — Baylis Medical Technologies Inc
- PowerWire Pro Radiofrequency Guidewire Kit — Baylis Medical Technologies Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Baylis Medical Technologies Inc
Sources (1)
- FDA UDI 491c7b3c-1053-4724-8ef9-eb22cdea8c57 36 fields · synced May 30, 2026