Acessa ProVu System

FDA UDI

Class II (US FDA UDI)

by Acessa Health Inc.

Identity

Trade Name: Acessa ProVu System FDA UDI
Generic Name: Radio-frequency ablation system FDA UDI
Device Name: Acessa ProVu System, Power Cord, Foot Pedal Assembly, Video Cable FDA UDI
Model / Reference: 7100 FDA UDI
Description: Acessa ProVu System, Power Cord, Foot Pedal Assembly, Video Cable FDA UDI

Identifiers

Primary DI / UDI-DI: 00854763006232 FDA UDI
FDA Product Code: ITX FDA UDI
IYO FDA UDI
OEW FDA UDI
HFG FDA UDI
GMDN Term: Radio-frequency ablation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1560 FDA UDI
882.4560 FDA UDI
884.4160 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radio-frequency ablation system

Acessa ProVu System by Acessa Health Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Radio-frequency ablation system.

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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 2188a710-8c4c-4c48-abbf-ef2bd91e012f 33 fields · synced May 30, 2026