Identity
- Trade Name
- Ellipsys Power Controller FDA UDI
- Generic Name
- Electrocautery system, line-powered FDA UDI
- Model / Reference
- AMI1000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B357AMI1000 FDA UDI
- 510(k) Number
- DEN170004 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
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 Power Controller — Avenu Medical · Class II
- Ellipsys Vascular Access System — 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
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 95d89ebe-cd45-4731-bd39-6897aab42aa8 34 fields · synced May 30, 2026