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SoundBite® Console

FDA UDI

Class II (US FDA UDI)

by Soundbite Medical Solutions, Inc.

Identity

Trade Name
SoundBite® Console FDA UDI
Generic Name
Mechanical atherectomy system generator, mechanical output FDA UDI
Device Name
The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.e., shock waves) which are transmitted to a connected SoundBite® Active Wire 14P and cause the distal tip of the active wire to move back and forth (axially), acting like a micro-jackhammer. After the passage of each pulse, the tip goes back to its original position. FDA UDI
Model / Reference
9AB-C001091 FDA UDI
Description
The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.e., shock waves) which are transmitted to a connected SoundBite® Active Wire 14P and cause the distal tip of the active wire to move back and forth (axially), acting like a micro-jackhammer. After the passage of each pulse, the tip goes back to its original position. FDA UDI

Identifiers

Primary DI / UDI-DI
17540265103028 FDA UDI
510(k) Number
K210839 FDA UDI
FDA Product Code
PDU FDA UDI
GMDN Term
Mechanical atherectomy system generator, mechanical output FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Weight — 80 Kilogram FDA UDI
Width — 13 Inch FDA UDI
Height — 42 Inch FDA UDI
Depth — 22 Inch FDA UDI

Category: Mechanical atherectomy system generator, mechanical output

SoundBite® Console by Soundbite Medical Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical atherectomy system generator, mechanical output.

Cleared under the same submission

K210839 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Soundbite Medical Solutions, Inc.

Sources (1)

  • FDA UDI b33bddab-abc1-43ee-baa5-205963682a40 37 fields · synced May 30, 2026