Identity
- Trade Name
- Acessa Pads FDA UDI
- Generic Name
- Radio-frequency ablation system FDA UDI
- Device Name
- Acessa Pads, disposable dispersive pad, connects to the Acessa ProVu Console Legacy #854763006010 FDA UDI
- Model / Reference
- 3000 FDA UDI
- Description
- Acessa Pads, disposable dispersive pad, connects to the Acessa ProVu Console Legacy #854763006010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854763006102 FDA UDI
- FDA Product Code
- HFG FDA UDIOEW FDA UDIIYO FDA UDIITX FDA UDI
- GMDN Term
- Radio-frequency ablation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4160 FDA UDI882.4560 FDA UDI892.1560 FDA UDI892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Radio-frequency ablation system
Acessa Pads by Acessa Health Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency ablation system.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- Cavi di connessione — ADVANCED MEDICAL SYSTEMS GROUP S.R.L. · Class I
- RF Ablation Electrode Kits — SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD. · Class IIb
- CP-16 TIP — Jeisys Medical Inc. · Class IIb
- 10THERMA Electrode — TENTECH Inc. · Class IIb
- DIAMOND TIP — Jeisys Medical Inc. · Class IIb
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- Halyard — Avanos Medical, Inc. · Class II
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
- Acessa Health Inc.
Sources (1)
- FDA UDI 211ab9b3-f8a4-4323-8624-7dcbcdd5011c 33 fields · synced May 30, 2026