Identity
- Trade Name
- Acessa ProVu System FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- The Acessa ProVu Handpiece is an RF ablation device to be connected to the Acessa ProVu System. The Acessa ProVu Handpiece is designed to function with or without tracking. The Acessa ProVu Handpiece is equipped with a slider knob to control the deployment and retraction of the needle array. FDA UDI
- Model / Reference
- 7300 FDA UDI
- Description
- The Acessa ProVu Handpiece is an RF ablation device to be connected to the Acessa ProVu System. The Acessa ProVu Handpiece is designed to function with or without tracking. The Acessa ProVu Handpiece is equipped with a slider knob to control the deployment and retraction of the needle array. FDA UDI
Identifiers
- Catalog Number
- 7300 FDA UDI
- Primary DI / UDI-DI
- 15420045515246 FDA UDI
- FDA Product Code
- HFG FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4160 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: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Acessa ProVu System by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Hologic, Inc.
Sources (1)
- FDA UDI 882ca7ae-e990-49bc-8a5e-e4389425262d 36 fields · synced May 31, 2026