Sonicision

FDA UDI

Class U (US FDA UDI)

by Covidien LP

Identity

Trade Name: Sonicision FDA UDI
Generic Name: Soft-tissue ultrasonic surgical system FDA UDI
Device Name: Reusable Generator FDA UDI
Model / Reference: SCGAA FDA UDI
Description: Reusable Generator FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521592865 FDA UDI
510(k) Number: K180149 FDA UDI
FDA Product Code: LFL FDA UDI
GMDN Term: Soft-tissue ultrasonic surgical system FDA UDI

Classification

Device Class: U 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: Soft-tissue ultrasonic surgical system

Sonicision by Covidien LP — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K180149 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 U	Pending data

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Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI f6e70943-8b3d-453b-b2cc-7c3317a61703 36 fields · synced May 30, 2026