Acu-Evac

FDA UDI

Class II (US FDA UDI)

by Acuderm, Inc.

Identity

Trade Name: ACU-EVAC FDA UDI
Generic Name: Surgical plume evacuation system FDA UDI
Device Name: Cart mount starter package includes Acu-Evac II unit, Cart, Boom Arm, Foot Switch, M-1 Main Filter, Hose and 5 TX Nozzles. FDA UDI
Model / Reference: STARTER-II FDA UDI
Description: Cart mount starter package includes Acu-Evac II unit, Cart, Boom Arm, Foot Switch, M-1 Main Filter, Hose and 5 TX Nozzles. FDA UDI

Identifiers

Primary DI / UDI-DI: 10814105020408 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

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

FDA UDI

Category: Surgical plume evacuation system

Acu-Evac by Acuderm, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Acuderm, Inc.

Sources (1)

FDA UDI e204bfbc-c9e5-44c8-a1f5-ac149250ff6b 35 fields · synced Jun 1, 2026