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VESALIUS STERILE single-use GLADIO needle electrode for microsurgery
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K152933
Identity
- Trade Name
- VESALIUS STERILE single-use GLADIO needle electrode for microsurgery FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Model / Reference
- STERILE, lf=3mm L=25mm GLADIO FDA UDI
Identifiers
- Catalog Number
- 2602054 FDA UDI
- Primary DI / UDI-DI
- 08034055294543 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
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: Open-surgery electrosurgical electrode, monopolar, single-use
VESALIUS STERILE single-use GLADIO needle electrode for microsurgery by Telea Electronic Engeenering Srl — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k)
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152933 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K131696 | Class II | Active |
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Manufacturer
- Manufacturer
- Telea Electronic Engeenering Srl
- FDA Applicant
- Telea Electronic Engineering Srl
Sources (2)
- FDA UDI 537518d9-1735-4b5f-9293-11ac61515242 57 fields · synced Jun 19, 2026
- FDA 510(k) K152933 1 fields · synced May 22, 2026