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Shockpulse

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
SHOCKPULSE FDA UDI
Generic Name
Ultrasonic lithotripsy system probe, single-use FDA UDI
Device Name
LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE, 2.9 Fr (0.97 mm) x 578 mm (3/PK) FDA UDI
Model / Reference
SPL-PDBX097 FDA UDI
Description
LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE, 2.9 Fr (0.97 mm) x 578 mm (3/PK) FDA UDI

Identifiers

Primary DI / UDI-DI
00821925044180 FDA UDI
510(k) Number
K171024 FDA UDI
FDA Product Code
FEO FDA UDI
GMDN Term
Ultrasonic lithotripsy system probe, single-use 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ultrasonic lithotripsy system probe, single-use

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, single-use.

Cleared under the same submission

K171024 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI 8e6e1070-c035-4a33-9b23-f151de0e7213 34 fields · synced May 29, 2026