Identity
- Trade Name
- ACU-EVAC FDA UDI
- Generic Name
- Surgical plume evacuation system FDA UDI
- Device Name
- Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or laparoscopic use. 110vac motor FDA UDI
- Model / Reference
- EVAC II-1 FDA UDI
- Description
- Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or laparoscopic use. 110vac motor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10814105020453 FDA UDI
- 510(k) Number
- K930043 FDA UDI
- FDA Product Code
- FYD FDA UDI
- GMDN Term
- Surgical plume evacuation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5070 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical plume evacuation system
Acu-Evac by Acuderm, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical plume evacuation system.
- MediMax Tech — MEDIMAX TECH INC. · Class II
- Megadyne — Megadyne Medical Products, Inc. · Class II
- Crystal Vision — I.C. Medical, Inc. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Opaque ULPA Filter & Water Trap — I.C. Medical, Inc. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- MediSourceNet, Inc — Medisourcenet, Inc · Class II
- MediMax Tech — MEDIMAX TECH INC. · Class II
Cleared under the same submission
K930043 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acuderm, Inc.
Sources (1)
- FDA UDI 332e3cf7-87c8-4916-b082-aaf887f12c8d 35 fields · synced Jun 1, 2026