Shockpulse

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: SHOCKPULSE FDA UDI
Generic Name: Ultrasonic lithotripsy system probe, reusable FDA UDI
Device Name: LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 4.5 Fr (1.50 mm) x 564 mm FDA UDI
Model / Reference: SPL-PR150 FDA UDI
Description: LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 4.5 Fr (1.50 mm) x 564 mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925043787 FDA UDI
510(k) Number: K142428 FDA UDI
FDA Product Code: FEO FDA UDI
GMDN Term: Ultrasonic lithotripsy system probe, reusable 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Ultrasonic lithotripsy system probe, reusable

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

Similar devices

Also classified as Ultrasonic lithotripsy system probe, reusable.

LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
UreTron Semi Rigid Sterile Probe 1.0 x 270 mm — Ultratellege USA Co. LTD. · Class II
UreTron Semi Rigid Sterile Probe 1.5 x 570 mm — Ultratellege USA Co. LTD. · Class II
UreTron Semi Rigid Sterile Probe 1.9 x 370 mm — Ultratellege USA Co. LTD. · Class II
LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
UreTron Semi Rigid Sterile Probe 1.5 x 480 mm — Ultratellege USA Co. LTD. · Class II
UreTron Rigid Sterile Probe 3.5 x 370 mm — Ultratellege USA Co. LTD. · Class II
UreTron Rigid Sterile Probe 3.1 x 370mm — Ultratellege USA Co. LTD. · Class II

Cleared under the same submission

K142428 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: Gyrus Acmi, Inc.

Sources (1)

FDA UDI ed274852-f1dd-4cc9-a276-17299b3579f6 35 fields · synced May 30, 2026