Ellipsys Power Controller

FDA UDI

Class II (US FDA UDI)

by Avenu Medical

Identity

Trade Name: Ellipsys Power Controller FDA UDI
Generic Name: Electrocautery system, line-powered FDA UDI
Device Name: The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter. FDA UDI
Model / Reference: AMI1001 FDA UDI
Description: The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter. FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000574710 FDA UDI
510(k) Number: K191114 FDA UDI
FDA Product Code: PQK FDA UDI
GMDN Term: Electrocautery system, line-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1252 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

Yes

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

MRI Safety

MR Conditional FDA UDI

Category: Electrocautery system, line-powered

Ellipsys Power Controller by Avenu Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocautery system, line-powered.

Geiger TCU 100 Handpiece — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
Ellipsys Vascular Access System — Avenu Medical · Class II
Ellipsys Power Controller — Avenu Medical · Class II
Ellipsys Vascular Access System — Avenu Medical · Class II
Ellipsys Vascular Access System — Avenu Medical · Class II
Ellipsys Power Controller — Avenu Medical · Class II
Ellipsys Power Controller — Avenu Medical · Class II

Cleared under the same submission

K191114 also covers:

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: Avenu Medical

Sources (1)

FDA UDI 2fead12c-71a3-4bbe-a171-72ae44e5c5b9 34 fields · synced May 31, 2026