Gyrus Acmi

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: GYRUS ACMI FDA UDI
Generic Name: Electrohydraulic lithotripsy system FDA UDI
Device Name: CYBERWAND POWER CORD FDA UDI
Model / Reference: CW-USLPC FDA UDI
Description: CYBERWAND POWER CORD FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925001428 FDA UDI
510(k) Number: K052135 FDA UDI
FDA Product Code: FFK FDA UDI
GMDN Term: Electrohydraulic lithotripsy system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4480 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Electrohydraulic lithotripsy system

Gyrus Acmi by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrohydraulic lithotripsy system.

EHL-Probe — Walz Elektronik GmbH · Class II
Autolith Uro-Touch — Northgate Technologies Inc. · Class II
EHL-Probe — Walz Elektronik GmbH · Class II
Electrohydraulic Lithotriptor — Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Class II
Econolith E3000 — Medispec, Ltd. · Class II
Autolith Touch — Northgate Technologies Inc. · Class II
EL27-Compact — Walz Elektronik GmbH · Class II
EHL Probe — Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 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: Gyrus Acmi, Inc.

Sources (1)

FDA UDI 7ac254d4-4865-420d-979b-9e87ffe8c601 34 fields · synced May 31, 2026